Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00256750
• Collaborator: (none)
• Enrollment: 738
• Locations: 105
• Arms: 3
• Duration (Months): 121
• Patients Per Site: 7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation; Chronic Kidney Failure	Drug: Cyclosporine (CsA); Drug: Belatacept LI (less intensive); Drug: Belatacept MI (more intensive)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 738 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cyclosporine (CsA)	Drug: Cyclosporine (CsA); tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
Experimental: Belatacept LI (less intensive)	Drug: Belatacept LI (less intensive); solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Experimental: Belatacept MI (more intensive)	Drug: Belatacept MI (more intensive); solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Outcome Measures

Primary Outcome Measures

1. Percent of Participants Surviving With a Functioning Graft by Month 12 [Day 1 to Month 12]

   Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.

2. Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12 [Month 12; Month 3 to Month 12]

   Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.

3. Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12 [Day 1 to Month 12]

   Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.

Secondary Outcome Measures

1. Mean Value of the Measured Glomerular Filtration Rate (mGFR) [Months 3, 12, 24]

   Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.

2. Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12 [Month 12]

   Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.

3. Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 [Randomization to Month 84]

   Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

4. Number of Participants With Adverse Events of Special Interest by Month 84 [Randomization to Month 84]

   Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.

5. Mean Blood Pressure at Month 84 [Month 84]

   Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.

6. Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 [Baseline to Month 36]

   Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L). Hemoglobin (low): <8.0 g/dL; Platelet count: <50*10^9 c/L; Leukocytes: <2*10^3 c/µL; Alkaline phosphatase (ALP): >5.0*ULN U/L; Alanine aminotransferase (ALT): >5.0*ULN U/L; Asparate aminotransferase (AST): >5.0*ULN U/L; Bilirubin Total: >3.0*ULN mg/dL; Creatinine: >3.0*ULN mg/dL; Calcium Total: low if <7.0 mg/dL or high if >12.5 mg/dL; Bicarbonate: <11.0 mEq/L; Potassium serum: low if <3.0 mEq/L or high if >6.0 mEq/L; Magnesium serum: low is <0.8 mEq/L or high if >2.46 mEq/L; Sodium serum: low if <130.0 mEq/L or high if >155.0 mEq/L; Phosphorus inorganic: <2.0 mg/dL; Albumin: <2 g/dL; Uric acid: >10 mg/dL; Protein urine: >=3+

7. Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84 [Randomization to Month 84]

   Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.

8. Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 [Month 3 to Month 12; Month 3 to Month 24]

   Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.

9. Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12 [Month 3 to Month 12]

   Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline

10. Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 [Month 12]

    Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).

11. Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation [Months 6, 12, 24, 36]

    Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2

12. Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12 [Month 6 to Month 12]

    Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m^2

13. Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 [Week 4 post-transplantation to Month 36]

    The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is >=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)

14. Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36 [Month 36]

    This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP < 130 mm Hg and a DBP < 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

15. Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12 [Month 12]

    The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

16. Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12 [Month 12]

    The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

17. Mean Systolic Blood Pressure and Diastolic Blood Pressure [Months 12, 24, 36]

    Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.

18. Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12 [Day 1 to Month 12]

    Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

19. Percent of Participants With Prevalence of Controlled Hypertension at Month 12 [Month 12]

    The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

20. Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12 [Randomization to Month 12]

    Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.

21. Percent of Participants With Prevalence of Dyslipidemia at Month 12 [Month 12]

    The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.

22. Percent of Participants With Controlled Dyslipidemia at Month 12 [Month 12]

    Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.

23. Number of Participants With Antihyperlipidemic Medication by Intensity Level [Month 36]

    An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.

24. Percent of Participants Using At Least One Anti-Hyperlipidemic Medication [Month 36]

    This analysis is based on all participants who were followed up at least 1092 days after transplantation.

25. Mean Value of Lipid Parameters [Months 12, 24, 36]

    Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).

26. Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 [Randomization to Month 36]

    Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.

27. Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 [Randomization to Month 36]

    Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.

28. Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12 [Randomization to Month 12]

    A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met >= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output < 250 mL/12 hours, no significant improvement (< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.

29. Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 [Randomization to Month 36]

    The use of LDT (thymoglobulin or antithymocyte gamma globulin [ATGAM]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.

30. Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 [Randomization to Month 36]

    Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.

31. Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 [Randomization to Month 12]

    Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine [SCr] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)

32. Percent of Participants With Subclinical Rejection at Month 12 [Month 12]

    Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.

33. Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 [Randomization to Month 36]

    Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.

34. Mean Value of Physical and Mental Components Using SF-36 Questionnaire [Months 6, 12, 24, 36]

    SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.

35. Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire [Months 6, 12, 24, 36]

    SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.

36. Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) [Months 6, 12, 24, 36]

    The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.

37. Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 [Baseline to Months 6, 12, 24,and 36]

    SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.

38. Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 [Baseline to Months 6, 12, 24, and 36]

    SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.

39. Percent of Participants Surviving With a Functioning Graft [Months 24, 36]

    Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.

40. Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 [Randomization to Month 36]

    Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject is a recipient of a living donor or deceased donor kidney transplant.

• Male or Female, 18 or older

Exclusion Criteria:

• First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.

• If retransplantation, previous graft loss cannot be due to acute rejection.

• Positive cross match.

• Subject receiving extended criteria donor (ECD) organ

• For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Alabama At Birmingham	Birmingham	Alabama	United States	35294
2	Loma Linda University Medical Center-Transplantation Institu	Loma Linda	California	United States	92354
3	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
4	California Institute Of Renal Research	San Diego	California	United States	92123
5	University Of California San Francisco Medical Center	San Francisco	California	United States	94143
6	University Of Colorado Health Sciences Center	Aurora	Colorado	United States	80045
7	Yale University School Of Medicine-Yale New Haven Hospital	New Haven	Connecticut	United States	06520
8	Piedmont Hospital	Atlanta	Georgia	United States	30309
9	Emory University Hospital	Atlanta	Georgia	United States	30322
10	Medical College Of Georgia	Augusta	Georgia	United States	30912
11	University Of Chicago Hospitals	Chicago	Illinois	United States	60637
12	University Of Iowa Hospitals And Clinics	Iowa City	Indiana	United States	52242
13	University Of Kentucky	Lexington	Kentucky	United States	40536
14	Maine Tranplant Program	Portland	Maine	United States	04102
15	Western New England Renal & Transplant Associates, Pc	Springfield	Massachusetts	United States	01107
16	Henry Ford Hospital, Transplant Institute	Detriot	Michigan	United States	48202
17	University Of Minnesota	Minneapolis	Minnesota	United States	55455
18	Washington University School Of Medicine	Saint Louis	Missouri	United States	63110
19	Recanati/Miller Transplantation Institute	New York	New York	United States	10029
20	Columbia University College Of Physicians & Surgeons	New York	New York	United States	10032
21	University Of Rochester Medical Center	Rochester	New York	United States	14642
22	University Of North Carolina At Chapel Hill	Chapel Hill	North Carolina	United States	27599
23	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
24	Duke University Medical Center	Durham	North Carolina	United States	27710
25	Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery	Philadelphia	Pennsylvania	United States	19102
26	Musc	Charleston	South Carolina	United States	29425
27	Vanderbilt University Medical Center	Nashville	Tennessee	United States	27232
28	Baylor University Medical Center	Dallas	Texas	United States	75246
29	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
30	Inova Transplant Center	Fairfax	Virginia	United States	22031
31	Swedish Medical Center	Seattle	Washington	United States	98104
32	Sacred Heart Medical Ctr Providence Medical Research Ctr	Spokane	Washington	United States	99204
33	University Of Wisconsin	Madison	Wisconsin	United States	53792
34	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin	United States	53226
35	Local Institution	Capital Federal	Buenos Aires	Argentina	C1425APQ
36	Local Institution	La Plata	Buenos Aires	Argentina	1900
37	Local Institution	Cordoba, Crd	Cordoba	Argentina	X5016KEH
38	Local Institution	Rosario	Santa Fe	Argentina	2000
39	Local Institution	Buenos Aires		Argentina	C1155APP
40	Local Institution	Santa Fe		Argentina	S3000EPV
41	Local Institution	Camperdown	New South Wales	Australia	2050
42	Local Institution	Westmead	New South Wales	Australia	2145
43	Local Institution	Adelaide	South Australia	Australia	5000
44	Local Institution	Parkville	Victoria	Australia	3052
45	Local Institution	Innsbuck		Austria	6020
46	Local Institution	Vienna		Austria	1090
47	Local Institution	Gent		Belgium	9000
48	Local Institution	Leuven		Belgium	3000
49	Local Institution	Rio De Janeiro / Rj	Rio De Janeiro	Brazil	21041
50	Local Institution	Porto Alegre/rs	Rio Grande Do Sul	Brazil	90035
51	Local Institution	Porto Alegre	Rio Grande Do Sul	Brazil	90035
52	Local Institution	Campinas	Sao Paulo	Brazil	13033
53	Local Institution	Sao Paulo/sp	Sao Paulo	Brazil	04038
54	Local Institution	Sao Paulo		Brazil	05403
55	Local Institution	Edmonton	Alberta	Canada	T6G 2S2
56	Local Institution	Halifax	Nova Scotia	Canada	B3H 2Y9
57	Local Institution	Montreal	Quebec	Canada	H1T 2M4
58	Local Institution	Montreal	Quebec	Canada	H2L 2W5
59	Local Institution	Montreal	Quebec	Canada	H3A 1A1
60	Local Institution	Saskatoon	Saskatchewan	Canada	S7M 0Z9
61	Local Institution	Praha 4		Czech Republic	140 21
62	Local Institution	Bordeaux		France	33076
63	Local Institution	Brest Cedex		France	29609
64	Local Institution	Creteil		France	94000
65	Local Institution	Grenoble Cedex 9		France	38043
66	Local Institution	Nante Cedex 01		France	44093
67	Local Institution	Paris		France	75015
68	Local Institution	Toulouse		France	31054
69	Local Institution	Berlin		Germany	13353
70	Local Institution	Erlangen		Germany	91054
71	Local Institution	Essen		Germany	45122
72	Local Institution	Hannover		Germany	30625
73	Local Institution	Szeged		Hungary	H-6720
74	Local Institution	Gujarat	Ahmedabad	India	380016
75	Local Institution	Nadiad	Gujarat	India	387001
76	Local Institution	Ahmedabad	Gujrat	India	380052
77	Local Institution	Cochin	Kerala	India	682304
78	Local Institution	Mumbai	Maharashtra	India	400 026
79	Local Institution	Mumbai	Maharashtra	India	400016
80	Local Institution	Chandigarh		India	160012
81	Local Institution	Chennai		India	600 006
82	Local Institution	Lucknow		India	226000
83	Local Institution	New Delhi		India	110076
84	Local Institution	Petah Tikva		Israel	49100
85	Local Institution	Milano		Italy	20162
86	Local Institution	Padova		Italy	35128
87	Local Institution	Roma		Italy	00168
88	Local Institution	Mexico	Distrito Federal	Mexico	14080
89	Local Institution	Cuernavaca	Morelos	Mexico	62448
90	Local Institution	Monterrey	Nuevo Leon	Mexico	64460
91	Local Institution	Aguascalientes		Mexico	20000
92	Local Institution	Distrito Federal		Mexico	14080
93	Local Institution	San Luis Potosi		Mexico	78240
94	Local Institution	Poznan		Poland	60-479
95	Local Institution	Szczecin		Poland	70-111
96	Local Institution	Observatory	Cape Town	South Africa	7925
97	Local Institution	Pretoria	Gauteng	South Africa	0002
98	Local Institution	Durban	Kwa Zulu Natal	South Africa	4001
99	Local Institution	Barcelona		Spain	08907
100	Local Institution	Madrid		Spain	28040
101	Local Institution	Malaga		Spain	29010
102	Local Institution	Goteborg		Sweden	SE-413 45
103	Local Institution	Bern		Switzerland	3010
104	Local Institution	Zurich		Switzerland	8091
105	Local Institution	Antalya		Turkey	07059

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS clinical trial educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00256750
• Other Study ID Numbers: IM103-008; NCT00432497
• First Posted: Nov 22, 2005
• Last Update Posted: Aug 19, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Cyclosporine; Abatacept; Cyclosporins

Study Results

Participant Flow

Pre-assignment Detail	738 participants enrolled, 686 randomized. Reasons for non-randomization include 5 participants withdrew consent, 1 lost to follow-up, 34 no longer met study criteria, and 12 for other non-listed reasons. 666 participants randomized, but not transplanted. 20 not transplanted; 10, 4, 6 in the CsA, Belatacept LI, Belatacept MI, respectively.

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Period Title: Transplanted Pre-Treatment
STARTED	221	226	219
COMPLETED	215	226	219
NOT COMPLETED	6	0	0
Period Title: Transplanted Pre-Treatment
STARTED	215	226	219
COMPLETED	174	183	173
NOT COMPLETED	41	43	46
Period Title: Transplanted Pre-Treatment
STARTED	174	183	173
COMPLETED	153	176	164
NOT COMPLETED	21	7	9
Period Title: Transplanted Pre-Treatment
STARTED	153	176	164
COMPLETED	143	170	158
NOT COMPLETED	10	6	6
Period Title: Transplanted Pre-Treatment
STARTED	136	166	155
COMPLETED	89	136	127
NOT COMPLETED	47	30	28

Baseline Characteristics

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI	Total
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Total of all reporting groups
Overall Participants	221	226	219	666
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (14.3)	42.6 (13.4)	43.6 (14.6)	43.2 (14.1)
Age, Customized (participants) [Number]
Between 18 and 45 years:	110 49.8%	124 54.9%	111 50.7%	345 51.8%
Between 46 and 65 years:	101 45.7%	93 41.2%	93 42.5%	287 43.1%
> 65 years:	10 4.5%	9 4%	15 6.8%	34 5.1%
Sex: Female, Male (Count of Participants)
Female	56 25.3%	80 35.4%	68 31.1%	204 30.6%
Male	165 74.7%	146 64.6%	151 68.9%	462 69.4%
Previous Number of Transplant (participants) [Number]
0	208 94.1%	218 96.5%	210 95.9%	636 95.5%
1	9 4.1%	5 2.2%	5 2.3%	19 2.9%
2	0 0%	0 0%	1 0.5%	1 0.2%
Missing	4 1.8%	3 1.3%	3 1.4%	10 1.5%

Outcome Measures

1. Primary Outcome

Title	Percent of Participants Surviving With a Functioning Graft by Month 12
Description	Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.
Time Frame	Day 1 to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Number (95% Confidence Interval) [percentage of participants]	92.8 42%	96.5 42.7%	95.4 43.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 97.3%; -1.1 to 9.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 97.3%; -2.5 to 8.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	If the lower bound of the CI (belatacept-CsA) was > -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.

2. Primary Outcome

Title	Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12
Description	Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.
Time Frame	Month 12; Month 3 to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	213	214	209
Number (95% Confidence Interval) [percentage of participants]	77.9 35.2%	54.2 24%	55.0 25.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Chi-squared, Corrected
	Comments	A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-23.7
	Confidence Interval	(2-Sided) 97.3%; -33.3 to -13.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Chi-squared, Corrected
	Comments	A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-22.9
	Confidence Interval	(2-Sided) 97.3%; -32.6 to -12.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12
Description	Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.
Time Frame	Day 1 to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Number (95% Confidence Interval) [percentage of participants]	7.2 3.3%	17.3 7.7%	21.9 10%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	10.0
	Confidence Interval	(2-Sided) 97.3%; 3.3 to 17.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 97.3%; 7.5 to 22.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

4. Secondary Outcome

Title	Mean Value of the Measured Glomerular Filtration Rate (mGFR)
Description	Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.
Time Frame	Months 3, 12, 24

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	201	215	209
Month 3 (n=201, 215, 209)	51.9 (21.09)	61.7 (25.43)	59.9 (28.47)
Month 12 (n=199, 206, 200)	50.4 (18.71)	63.4 (27.66)	65.0 (30.02)
Month 24 (n=185, 199, 192)	50.5 (20.52)	67.9 (29.90)	65.0 (27.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Time Frame = Day 1 to Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.
	Method	Kruskal-Wallis
	Comments	Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.0
	Confidence Interval	(2-Sided) 97.3%; 7.3 to 18.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Test were conducted at a level of 0.027 (2-sided).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Time Frame = Day 1 to Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.
	Method	Kruskal-Wallis
	Comments	Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.6
	Confidence Interval	(2-Sided) 97.3%; 8.9 to 20.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Test were conducted at a level of 0.027 (2-sided).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Time Frame = Day 1 to Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.
	Method	Kruskal-Wallis
	Comments	Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	17.4
	Confidence Interval	(2-Sided) 97.3%; 11.5 to 23.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Test were conducted at a level of 0.027 (2-sided).

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Time Frame = Day 1 to Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.
	Method	Kruskal-Wallis
	Comments	Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.5
	Confidence Interval	(2-Sided) 97.3%; 8.5 to 20.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Test were conducted at a level of 0.027 (2-sided).

5. Secondary Outcome

Title	Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12
Description	Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	219	226	219
Number (95% Confidence Interval) [percentage of participants]	32.4 14.7%	23.9 10.6%	18.3 8.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.
Statistical Test of Hypothesis	p-Value	0.0581
	Comments
	Method	Chi-squared, Corrected
	Comments	A continuity corrected chi-square test at a significance level of 0.027 was performed.
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-8.5
	Confidence Interval	(2-Sided) 97.3%; -17.9 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.
Statistical Test of Hypothesis	p-Value	0.0010
	Comments
	Method	Chi-squared, Corrected
	Comments	A continuity corrected chi-square test at a significance level of 0.027 was performed.
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-14.2
	Confidence Interval	(2-Sided) 97.3%; -23.2 to -5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84
Description	Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time Frame	Randomization to Month 84

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	136	166	155
Deaths	9 4.1%	7 3.1%	7 3.2%
SAEs	107 48.4%	113 50%	117 53.4%
Discontinued due to SAEs	5 2.3%	8 3.5%	6 2.7%
Discontinued due to AEs	12 5.4%	11 4.9%	14 6.4%

7. Secondary Outcome

Title	Number of Participants With Adverse Events of Special Interest by Month 84
Description	Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.
Time Frame	Randomization to Month 84

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	136	166	155
Malignancies	22 10%	16 7.1%	20 9.1%
Cytomegalovirus (CMV) Infections	19 8.6%	24 10.6%	20 9.1%
BK Polyoma Virus Infections	6 2.7%	10 4.4%	15 6.8%
Herpes Virus Infections	29 13.1%	37 16.4%	37 16.9%
Fungal Infections	42 19%	47 20.8%	55 25.1%
Tuberculosis Infections	2 0.9%	1 0.4%	5 2.3%
Central Nervous System (CNS) Infections	0 0%	0 0%	1 0.5%
Pulmonary edema or Congestive Heart Failure	12 5.4%	4 1.8%	5 2.3%
Auto-immune Events	8 3.6%	8 3.5%	6 2.7%

8. Secondary Outcome

Title	Mean Blood Pressure at Month 84
Description	Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.
Time Frame	Month 84

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	136	166	155
Diastolic Blood Pressure (n=82, 125, 112)	78.6 (11.03)	75.8 (10.56)	75.1 (10.15)
Systolic Blood Pressure (n=82, 125, 112)	129.0 (15.83)	126.7 (18.17)	126.0 (17.56)

9. Secondary Outcome

Title	Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36
Description	Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L). Hemoglobin (low): <8.0 g/dL; Platelet count: <50*10^9 c/L; Leukocytes: <2*10^3 c/µL; Alkaline phosphatase (ALP): >5.0*ULN U/L; Alanine aminotransferase (ALT): >5.0*ULN U/L; Asparate aminotransferase (AST): >5.0*ULN U/L; Bilirubin Total: >3.0*ULN mg/dL; Creatinine: >3.0*ULN mg/dL; Calcium Total: low if <7.0 mg/dL or high if >12.5 mg/dL; Bicarbonate: <11.0 mEq/L; Potassium serum: low if <3.0 mEq/L or high if >6.0 mEq/L; Magnesium serum: low is <0.8 mEq/L or high if >2.46 mEq/L; Sodium serum: low if <130.0 mEq/L or high if >155.0 mEq/L; Phosphorus inorganic: <2.0 mg/dL; Albumin: <2 g/dL; Uric acid: >10 mg/dL; Protein urine: >=3+
Time Frame	Baseline to Month 36

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Hemoglobin, low (n=213, 226, 219)	26 11.8%	25 11.1%	27 12.3%
Platelet count, low (n=213, 226, 218)	0 0%	1 0.4%	0 0%
Leukocytes, low (n=213, 226, 219)	10 4.5%	5 2.2%	5 2.3%
Alkaline phosphatase, high (n=214, 226, 219)	1 0.5%	4 1.8%	0 0%
Alanine aminotransferase, high (n=214, 226, 219)	6 2.7%	6 2.7%	4 1.8%
Aspartate aminotransferase, high (n=214, 226, 219)	2 0.9%	3 1.3%	3 1.4%
Bilirubin total, high (n=214, 226, 219)	1 0.5%	0 0%	0 0%
Creatinine, high (n=213, 223, 219)	48 21.7%	50 22.1%	52 23.7%
Calcium total, low (n=214, 226, 219)	7 3.2%	8 3.5%	4 1.8%
Calcium total, high (n=214, 226, 219)	0 0%	1 0.4%	0 0%
Bicarbonate, low (n=214, 226, 219)	1 0.5%	0 0%	0 0%
Bicarbonate, high (n=214, 226, 219)	0 0%	0 0%	0 0%
Potassium serum, low (n=213, 223, 219)	4 1.8%	13 5.8%	12 5.5%
Potassium serum, high (n=213, 223, 219)	13 5.9%	9 4%	4 1.8%
Magnessium serum, low (n=214, 225, 219)	1 0.5%	2 0.9%	1 0.5%
Magnessium serum, high (n=214, 225, 219)	9 4.1%	12 5.3%	14 6.4%
Sodium serum, low (n=214, 226, 219)	21 9.5%	8 3.5%	9 4.1%
Sodium serum, high (n=214, 226, 219)	0 0%	1 0.4%	0 0%
Phosphorus inorganic, low (n=213, 224, 219)	75 33.9%	100 44.2%	112 51.1%
Albumin, low (n=214, 226, 219)	0 0%	0 0%	0 0%
Uric acid, high (n=214, 226, 219)	42 19%	7 3.1%	11 5%
Protein in urine, high (n=213, 224, 217)	33 14.9%	30 13.3%	36 16.4%

10. Secondary Outcome

Title	Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84
Description	Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.
Time Frame	Randomization to Month 84

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	215	226	219
Number (95% Confidence Interval) [percentage of participants]	11.6 5.2%	3.1 1.4%	1.4 0.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Percent treatment difference measured as Belatacept - LI minus Cyclosporine
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-8.5
	Confidence Interval	(2-Sided) 97.3%; -14.6 to -3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Percent treatment difference measured as Belatacept - LI minus Cyclosporine
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-10.3
	Confidence Interval	(2-Sided) 97.3%; -16.1 to -5.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

11. Secondary Outcome

Title	Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24
Description	Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.
Time Frame	Month 3 to Month 12; Month 3 to Month 24

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	195	206	200
Baseline (Month 3) to Month 12 (n=195, 206, 200)	-1.7 (21.58)	1.2 (30.43)	4.4 (31.10)
Baseline (Month 3) to Month 24 (n=184, 199, 192)	-2.0 (25.23)	5.3 (33.03)	4.2 (30.96)

12. Secondary Outcome

Title	Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12
Description	Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline
Time Frame	Month 3 to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	213	214	209
Number (95% Confidence Interval) [percentage of participants]	28.2 12.8%	23.4 10.4%	23.0 10.5%

13. Secondary Outcome

Title	Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12
Description	Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	213	214	209
Number (95% Confidence Interval) [percentage of participants]	67.6 30.6%	43 19%	43.5 19.9%

14. Secondary Outcome

Title	Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation
Description	Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2
Time Frame	Months 6, 12, 24, 36

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	199	201	201
Month 6 (n=189, 185, 170)	48.8 (19.22)	62.6 (20.41)	62.4 (20.94)
Month 12 (n=199, 200, 201)	50.1 (21.06)	65.4 (22.94)	65.2 (23.51)
Month 24 (n=182, 201, 191)	47.9 (23.00)	65.4 (25.22)	65.5 (24.87)
Month 36 (n=171, 190, 186)	44.4 (23.58)	65.8 (27.00)	65.2 (26.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	15.3
	Confidence Interval	(2-Sided) 97.3%; 10.3 to 20.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANOVA model: GFR = treatment

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	15.1
	Confidence Interval	(2-Sided) 97.3%; 10.1 to 20.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANOVA model: GFR = treatment

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	17.5
	Confidence Interval	(2-Sided) 97.3%; 12.0 to 23.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANOVA model: GFR = treatment

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	17.6
	Confidence Interval	(2-Sided) 97.3%; 12.0 to 23.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANOVA model: GFR = treatment

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	21.4
	Confidence Interval	(2-Sided) 97.3%; 15.4 to 27.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANOVA model: GFR = treatment

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	20.8
	Confidence Interval	(2-Sided) 97.3%; 14.8 to 26.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANOVA model: GFR = treatment

15. Secondary Outcome

Title	Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12
Description	Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m^2
Time Frame	Month 6 to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	166	169	160
Mean (Standard Deviation) [mL/Min/1.73 m^2]	2.3 (10.09)	4.7 (11.52)	5.1 (11.37)

16. Secondary Outcome

Title	Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36
Description	The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is >=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)
Time Frame	Week 4 post-transplantation to Month 36

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	162	168	156
Month 12	9.9 4.5%	4.2 1.9%	7.1 3.2%
Month 24	10.5 4.8%	5.4 2.4%	8.3 3.8%
Month 36	11.1 5%	6.5 2.9%	10.3 4.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0687
	Comments	Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 97.3%; -12.6 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4825
	Comments	Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-2.8
	Confidence Interval	(2-Sided) 97.3%; -10.2 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1267
	Comments	Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-5.1
	Confidence Interval	(2-Sided) 97.3%; -12.3 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6405
	Comments	Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 97.3%; -9.8 to 5.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2043
	Comments
	Method	Chi-squared
	Comments	Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-4.6
	Confidence Interval	(2-Sided) 97.3%; -12.0 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9481
	Comments	Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 97.3%; -8.8 to 7.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36
Description	This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP < 130 mm Hg and a DBP < 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	182	199	192
Number (95% Confidence Interval) [percentage of participants]	92.9 42%	81.9 36.2%	83.9 38.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 97.3%; 0.31 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is estimated by a cumulative logit model.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0092
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 97.3%; 0.38 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is estimated by a cumulative logit model.

18. Secondary Outcome

Title	Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12
Description	The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	4	13	7
Number (95% Confidence Interval) [percentage of participants]	75.0 33.9%	53.8 23.8%	57.1 26.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-21.2
	Confidence Interval	(2-Sided) 97.3%; -67.6 to 43.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-17.9
	Confidence Interval	(2-Sided) 97.3%; -72.3 to 52.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

19. Secondary Outcome

Title	Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12
Description	The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Number (95% Confidence Interval) [percentage of participants]	91.0 41.2%	89.8 39.7%	88.6 40.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 97.3%; -7.51 to 5.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-2.37
	Confidence Interval	(2-Sided) 97.3%; -9.01 to 4.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

20. Secondary Outcome

Title	Mean Systolic Blood Pressure and Diastolic Blood Pressure
Description	Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.
Time Frame	Months 12, 24, 36

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	188	193	191
Systolic; Month 12 (n=188, 193, 191)	138.7 (19.98)	131.4 (16.54)	132.7 (16.21)
Diastolic; Month 12 (n=188, 193, 191)	81.9 (11.10)	78.7 (10.91)	79.3 (11.54)
Systolic; Month 24 (n=160, 185, 174)	135.4 (19.71)	130.5 (17.35)	129.8 (16.84)
Diastolic; Month 24 (n=160, 185, 174)	80.3 (10.20)	78.3 (10.51)	77.8 (10.31)
Systolic; Month 36 (n=145, 180, 166)	133.5 (17.93)	127.7 (16.48)	126.0 (16.14)
Diastolic; Month 36 (n=145, 180, 166)	79.5 (9.16)	76.6 (9.75)	76.1 (11.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Systolic, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-7.3
	Confidence Interval	(2-Sided) 97.3%; -11.4 to -3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Systolic, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 97.3%; -10.1 to -2.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Diastolic, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-3.2
	Confidence Interval	(2-Sided) 97.3%; -5.8 to -0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Diastolic, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 97.3%; -5.1 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Systolic, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-4.9
	Confidence Interval	(2-Sided) 97.3%; -9.2 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Systolic, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 97.3%; -9.9 to -1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Diastolic, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 97.3%; -4.4 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Diastolic, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 97.3%; -5.0 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Systolic, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-5.8
	Confidence Interval	(2-Sided) 97.3%; -10.0 to -1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Systolic, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-7.5
	Confidence Interval	(2-Sided) 97.3%; -11.7 to -3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Diastolic, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-2.9
	Confidence Interval	(2-Sided) 97.3%; -5.4 to -0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Diastolic, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 97.3%; -6.0 to -0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12
Description	Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time Frame	Day 1 to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	182	182	183
Number (95% Confidence Interval) [percentage of participants]	21.4 9.7%	28.6 12.7%	24.6 11.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	At Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	7.1
	Confidence Interval	(2-Sided) 97.3%; -2.9 to 17.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	At Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 97.3%; -6.6 to 12.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine

22. Secondary Outcome

Title	Percent of Participants With Prevalence of Controlled Hypertension at Month 12
Description	The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	186	193	190
Number (95% Confidence Interval) [percentage of participants]	21.0 9.5%	28.0 12.4%	24.7 11.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	7.01
	Confidence Interval	(2-Sided) 97.3%; -2.79 to 16.71
	Parameter Dispersion	Type: Value:
	Estimation Comments	A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	3.77
	Confidence Interval	(2-Sided) 97.3%; -5.86 to 13.35
	Parameter Dispersion	Type: Value:
	Estimation Comments	A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine

23. Secondary Outcome

Title	Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12
Description	Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.
Time Frame	Randomization to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	75	94	79
Number (95% Confidence Interval) [percentage of participants]	80.0 36.2%	63.8 28.2%	70.9 32.4%

24. Secondary Outcome

Title	Percent of Participants With Prevalence of Dyslipidemia at Month 12
Description	The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Number (95% Confidence Interval) [percentage of participants]	52.9 23.9%	44.7 19.8%	46.1 21.1%

25. Secondary Outcome

Title	Percent of Participants With Controlled Dyslipidemia at Month 12
Description	Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent-to-treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Number (95% Confidence Interval) [percentage of participants]	18.1 8.2%	15.5 6.9%	15.5 7.1%

26. Secondary Outcome

Title	Number of Participants With Antihyperlipidemic Medication by Intensity Level
Description	An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	103	92	92
Intensity Level I	17 7.7%	15 6.6%	17 7.8%
Intensity Level II	46 20.8%	27 11.9%	39 17.8%
Intensity Level III	27 12.2%	32 14.2%	23 10.5%
Intensity Level IV	8 3.6%	16 7.1%	9 4.1%
Intensity Level V	4 1.8%	1 0.4%	4 1.8%
Intensity Level VI	1 0.5%	1 0.4%	0 0%

27. Secondary Outcome

Title	Percent of Participants Using At Least One Anti-Hyperlipidemic Medication
Description	This analysis is based on all participants who were followed up at least 1092 days after transplantation.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	182	199	192
Number (95% Confidence Interval) [percentage of participants]	56.6 25.6%	46.2 20.4%	47.9 21.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-10.4
	Confidence Interval	(2-Sided) 97.3%; -21.4 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-8.7
	Confidence Interval	(2-Sided) 97.3%; -19.9 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

28. Secondary Outcome

Title	Mean Value of Lipid Parameters
Description	Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).
Time Frame	Months 12, 24, 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent-to-treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	189	195	192
non-HDL Cholesterol; Month 12 (n=189, 195, 192)	144.1 (47.31)	131.5 (38.18)	131.7 (36.76)
Total Cholesterol; Month 12 (n=189, 195, 192)	191.5 (49.29)	182.4 (39.78)	181.3 (39.92)
HDL Cholesterol; Month 12 (n=189, 195, 192)	47.4 (13.33)	50.8 (15.98)	49.7 (15.69)
LDL Cholesterol; Month 12 (n=187, 186, 183)	107.3 (39.60)	102.1 (33.40)	100.8 (29.48)
Triglyceride; Month 12 (n=187, 186, 183)	184.6 (106.42)	149.4 (87.25)	155.0 (85.08)
non-HDL Cholesterol; Month 24 (n=166, 190, 181)	145.1 (39.52)	126.7 (38.48)	127.0 (36.76)
Total Cholesterol; Month 24 (n=166, 190, 181)	193.5 (40.23)	175.3 (42.38)	175.4 (40.03)
HDL ; Month 24 (n=166, 190, 181)	48.4 (13.74)	48.6 (15.28)	48.5 (14.92)
LDL Cholesterol; Month 24 (n=164, 186, 168)	109.1 (35.92)	98.6 (33.71)	96.5 (30.52)
Triglyceride; Month 24 (n=164, 186, 168)	179.5 (97.51)	143.4 (88.97)	151.2 (95.88)
non-HDL Cholesterol; Month 36 (n=154, 184, 176)	142.2 (43.19)	122.4 (40.12)	122.1 (38.78)
Total Cholesterol; Month 36 (n=154, 184, 176)	190.7 (45.28)	171.3 (45.78)	170.7 (43.26)
HDL Cholesterol; Month 36 (n=154, 184, 176)	48.5 (14.27)	48.9 (15.37)	48.6 (16.86)
LDL Cholesterol; Month 36 (n=142, 170, 161)	107.6 (37.66)	96.7 (36.53)	92.5 (33.78)
Triglyceride; Month 36 (n=142, 170, 161)	179.1 (97.07)	132.7 (68.69)	144.0 (81.48)

29. Secondary Outcome

Title	Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36
Description	Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.
Time Frame	Randomization to Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Month 6 (n=221, 226, 219)	5.4 2.4%	16.8 7.4%	21.9 10%
Month 24 (n=221, 226, 219)	9.0 4.1%	17.3 7.7%	24.2 11.1%
Month 36 (n=221, 226, 219)	9.5 4.3%	17.3 7.7%	24.2 11.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 6
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	11.4
	Confidence Interval	(2-Sided) 97.3%; 5.0 to 18.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 6
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	16.5
	Confidence Interval	(2-Sided) 97.3%; 9.6 to 23.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 24
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	8.2
	Confidence Interval	(2-Sided) 97.3%; 1.2 to 15.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 24
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	15.2
	Confidence Interval	(2-Sided) 97.3%; 7.5 to 23.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 36
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	7.8
	Confidence Interval	(2-Sided) 97.3%; 0.6 to 15.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 36
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 97.3%; 7.0 to 22.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

30. Secondary Outcome

Title	Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36
Description	Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.
Time Frame	Randomization to Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Mild Acute (IA); Month 6	1 0.5%	4 1.8%	7 3.2%
Mild Acute (IB); Month 6	5 2.3%	9 4%	3 1.4%
Moderate Acute (IIA); Month 6	5 2.3%	14 6.2%	16 7.3%
Moderate Acute (IIB); Month 6	1 0.5%	10 4.4%	20 9.1%
Severe Acute (III); Month 6	0 0%	1 0.4%	2 0.9%
Mild Acute (IA); Month 12	3 1.4%	4 1.8%	7 3.2%
Mild Acute (IB); Month 12	5 2.3%	8 3.5%	3 1.4%
Moderate Acute (IIA); Month 12	6 2.7%	16 7.1%	17 7.8%
Moderate Acute (IIB); Month 12	2 0.9%	10 4.4%	20 9.1%
Severe Acute (III); Month 12	0 0%	1 0.4%	2 0.9%
Mild Acute (IA); Month 24	4 1.8%	4 1.8%	7 3.2%
Mild Acute (IB); Month 24	7 3.2%	8 3.5%	3 1.4%
Moderate Acute (IIA); Month 24	6 2.7%	16 7.1%	18 8.2%
Moderate Acute (IIB); Month 24	3 1.4%	10 4.4%	22 10%
Severe Acute (III); Month 24	0 0%	1 0.4%	3 1.4%
Mild Acute (IA); Month 36	5 2.3%	4 1.8%	7 3.2%
Mild Acute (IB); Month 36	7 3.2%	8 3.5%	3 1.4%
Moderate Acute (IIA); Month 36	6 2.7%	16 7.1%	18 8.2%
Moderate Acute (IIB); Month 36	3 1.4%	10 4.4%	22 10%
Severe Acute (III); Month 36	0 0%	1 0.4%	3 1.4%

31. Secondary Outcome

Title	Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12
Description	A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met >= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output < 250 mL/12 hours, no significant improvement (< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.
Time Frame	Randomization to Month 12

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Number (95% Confidence Interval) [percentage of participants]	3.6 1.6%	0.4 0.2%	0.5 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-3.2
	Confidence Interval	(2-Sided) 95%; -6.6 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 95% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-3.2
	Confidence Interval	(2-Sided) 95%; -6.6 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	For 95% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.

32. Secondary Outcome

Title	Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36
Description	The use of LDT (thymoglobulin or antithymocyte gamma globulin [ATGAM]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.
Time Frame	Randomization to Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Month 6	0.5 0.2%	4.4 1.9%	5.9 2.7%
Month 12	0.9 0.4%	4.4 1.9%	5.9 2.7%
Month 24	1.4 0.6%	4.4 1.9%	5.9 2.7%
Month 36	1.8 0.8%	4.4 1.9%	5.9 2.7%

33. Secondary Outcome

Title	Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36
Description	Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.
Time Frame	Randomization to Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Month 6	0.0 0%	4.0 1.8%	5.9 2.7%
Month 12	0.0 0%	5.3 2.3%	6.4 2.9%
Month 24	0.5 0.2%	5.3 2.3%	6.4 2.9%
Month 36	0.5 0.2%	5.3 2.3%	6.8 3.1%

34. Secondary Outcome

Title	Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12
Description	Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine [SCr] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)
Time Frame	Randomization to Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	16	39	48
Algorithm 1	13 5.9%	29 12.8%	39 17.8%
Algorithm 2	13 5.9%	34 15%	43 19.6%

35. Secondary Outcome

Title	Percent of Participants With Subclinical Rejection at Month 12
Description	Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	155	170	164
Number (95% Confidence Interval) [percentage of participants]	5.2 2.4%	4.7 2.1%	4.3 2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 97.3%; -6.5 to 5.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 97.3%; -6.9 to 4.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

Title	Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36
Description	Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.
Time Frame	Randomization to Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Month 6	43 19.5%	68 30.1%	70 32%
Month 12	56 25.3%	72 31.9%	75 34.2%
Month 24	63 28.5%	74 32.7%	81 37%
Month 36	69 31.2%	76 33.6%	82 37.4%

37. Secondary Outcome

Title	Mean Value of Physical and Mental Components Using SF-36 Questionnaire
Description	SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time Frame	Months 6, 12, 24, 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	203	218	201
Mental Component Score; Month 6 (n=191, 205, 189)	49.4 (11.08)	49.9 (10.55)	51.1 (10.53)
Physical Component Score; Month 6 (n=191,205,189)	47.3 (8.91)	48.9 (8.59)	49.2 (7.58)
Mental Component Score; Month 12 (n=198,210,194)	49.5 (10.78)	50.3 (10.08)	49.9 (10.54)
Physical Component Score; Month 12 (n=198,210,194)	47.5 (9.34)	49.6 (8.18)	50.3 (8.21)
Mental Component Score; Month 24 (n=200,214,198)	48.3 (11.14)	49.6 (10.77)	48.8 (11.03)
Physical Component Score; Month 24 (n=200,214,198)	47.3 (9.50)	49.0 (8.77)	49.9 (8.03)
Mental Component Score; Month 36 (n=203,218,201)	46.9 (11.60)	48.7 (11.26)	48.3 (11.50)
Physical Component Score; Month 36 (n=203,218,201)	47.1 (9.47)	49.2 (9.15)	48.7 (8.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6573
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; -1.6 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1198
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -0.4 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0672
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.1 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0257
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 0.2 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4146
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.2 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7327
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.7 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0144
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 0.4 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0015
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; 1.1 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2340
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.8 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6635
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; -1.7 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0417
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 0.1 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0026
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; 0.9 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0953
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.3 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1961
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.8 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0191
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 0.3 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0684
	Comments	Baseline observations were not used for imputations at subsequent time points.
	Method	ANOVA
	Comments	ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -0.1 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

38. Secondary Outcome

Title	Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire
Description	SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time Frame	Months 6, 12, 24, 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	205	219	206
Bodily Pain, Month 6 (n=193, 207, 193)	50.6 (10.96)	52.5 (10.10)	52.7 (10.04)
General Health, Month 6 (n=193, 207, 194)	47.9 (10.08)	48.2 (9.67)	49.0 (8.66)
Mental Health, Month 6 (n=192, 206, 194)	50.1 (11.08)	50.3 (10.33)	51.3 (10.78)
Physical Functioning, Month 6 (n=193, 207, 194)	47.4 (9.13)	48.3 (9.01)	48.0 (8.81)
Role Emotional, Month 6 (n=192, 206, 191)	44.6 (12.31)	46.0 (11.19)	46.8 (10.55)
Role-Physical, Month 6 (n=192, 207, 192)	43.2 (11.08)	45.2 (10.34)	46.7 (9.06)
Social Functioning, Month 6 (n=193, 207, 194)	47.5 (10.68)	47.8 (10.41)	47.9 (10.65)
Vitality, Month 6 (n=192, 206, 194)	54.0 (10.27)	55.5 (9.75)	56.2 (9.29)
Bodily Pain, Month 12 (n=200, 213, 199)	50.8 (10.79)	52.7 (9.67)	53.7 (9.60)
General Health, Month 12 (n=200, 214, 199)	46.9 (9.98)	48.8 (9.57)	49.2 (8.85)
Mental Health, Month 12 (n=200, 213, 199)	49.8 (10.99)	50.7 (10.64)	50.3 (10.29)
Physical Functioning, Month 12 (n=200, 214, 198)	47.2 (9.77)	49.0 (8.88)	48.1 (9.84)
Role Emotional, Month 12 (n=198, 213, 196)	45.8 (11.36)	46.8 (10.82)	45.9 (11.27)
Role-Physical, Month 12 (n=199, 213, 196)	45.0 (10.78)	47.1 (10.00)	47.5 (9.90)
Social Functioning, Month 12 (n=200, 213, 199)	47.6 (10.26)	48.4 (9.61)	49.1 (9.80)
Vitality, Month 12 (n=200, 213, 199)	53.3 (10.01)	55.7 (9.81)	56.0 (9.34)
Bodily Pain, Month 24 (n=203, 219, 205)	51.0 (10.82)	51.4 (10.51)	52.5 (10.47)
General Health, Month 24 (n=203, 219, 205)	46.2 (10.07)	48.4 (9.61)	48.7 (9.45)
Mental Health, Month 24 (n=201, 215, 199)	48.5 (11.13)	49.7 (10.89)	49.3 (10.85)
Physical Functioning, Month 24 (n=203, 219, 205)	46.5 (10.69)	48.7 (9.76)	48.0 (10.24)
Role Emotional, Month 24 (n=202, 218, 205)	44.8 (12.54)	46.4 (10.89)	46.0 (10.88)
Role-Physical, Month 24 (n=203, 219, 204)	44.1 (11.61)	46.6 (10.39)	48.0 (9.33)
Social Functioning, Month 24 (n=203, 219, 205)	47.3 (10.64)	48.6 (10.28)	47.7 (10.23)
Vitality, Month 24 (n=201, 215, 200)	52.5 (10.58)	54.5 (10.30)	54.2 (10.30)
Bodily Pain, Month 36 (n=204, 219, 205)	50.0 (11.40)	52.3 (10.40)	51.0 (11.05)
General Health, Month 36 (n=205, 219, 206)	45.5 (10.12)	47.7 (10.45)	47.5 (9.93)
Mental Health, Month 36 (n=203, 219, 204)	47.4 (11.64)	48.9 (11.52)	48.7 (11.43)
Physical Functioning, Month 36 (n=204, 218, 206)	46.8 (9.92)	48.1 (10.22)	47.8 (10.12)
Role Emotional, Month 36 (n=204, 219, 205)	43.5 (12.18)	46.0 (11.85)	45.3 (11.67)
Role-Physical, Month 36 (n=204, 219, 205)	43.6 (10.73)	46.3 (11.03)	46.2 (10.03)
Social Functioning, Month 36 (n=204, 219, 206)	46.6 (10.68)	48.1 (10.28)	47.1 (10.66)
Vitality, Month 36 (n=203, 219, 204)	51.4 (10.48)	53.6 (11.38)	53.4 (10.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Bodily Pain, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0714
	Comments
	Method	ANOVA
	Comments	Domain Score = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.2 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Bodily Pain, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0536
	Comments
	Method	ANOVA
	Comments	Domain score = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -0.0 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	General Health, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7543
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -1.6 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	General Health, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2499
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -0.8 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Health, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8332
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -1.9 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Health, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2523
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.9 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Functioning, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3018
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.8 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Functioning, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5437
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -1.2 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role Emotional, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2370
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.9 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role Emotional, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0588
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; -0.1 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role Physical, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0502
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -0.0 to 4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role-Physical, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 1.5 to 5.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Social Functioning, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7637
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -1.8 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Social Functioning, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7006
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.7 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Vitality, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1222
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.4 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Vitality, Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0289
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 0.2 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Bodily Pain, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0571
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.1 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Bodily Pain, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0042
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; 0.9 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	General Health, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0423
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 0.1 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	General Health, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0174
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.4 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Health, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3630
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.1 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Health, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6319
	Comments
	Method	ANOVA
	Comments	Missing data were imputed by LOCF
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; -1.6 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Functioning, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0503
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -0.0 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Functioning, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3291
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.9 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role Emotional, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3860
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.2 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role Emotional, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9672
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.2 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role-Physical, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0392
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 0.1 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role-Physical, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0151
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 0.5 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Social Functioning, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3978
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.1 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Social Functioning, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1263
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.4 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Vitality, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0160
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.4 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Vitality, Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0075
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 0.7 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Bodily Pain, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6990
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.6 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Bodily Pain, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1608
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.6 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	General Health, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0214
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 0.3 to 4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	General Health, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.00886
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 0.6 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Health, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2555
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.9 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Health, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4804
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.4 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Functioning, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0276
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 0.2 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Functioning, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1285
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.4 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role Emotional, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1352
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -0.5 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role Emotional, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2663
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -1.0 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role-Physical, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0164
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 0.5 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role-Physical, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; 1.9 to 5.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Social Functioning, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1914
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.7 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Social Functioning, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6882
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.6 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Vitality, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0547
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -0.0 to 4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Vitality, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0992
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -0.3 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Bodily Pain, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0339
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.2 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Bodily Pain, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3572
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.1 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	General Health, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0211
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.3 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	General Health, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0450
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; 0.0 to 4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Health, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1710
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.7 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Health, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2484
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.9 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Functioning, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1836
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.6 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Functioning, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3303
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role Emotional, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0299
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 0.2 to 4.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role Emotional, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1141
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.4 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Role-Physical, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0087
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; 0.7 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Role-Physical, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0128
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 0.6 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 61

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Social Functioning, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1369
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.5 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 62

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Social Functioning, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6331
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; -1.5 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 63

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Vitality, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0361
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 0.1 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

Statistical Analysis 64

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Vitality, Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0525
	Comments
	Method	ANOVA
	Comments	Missing data = treatment
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; -0.0 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Missing data were imputed by LOCF

39. Secondary Outcome

Title	Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)
Description	The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.
Time Frame	Months 6, 12, 24, 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population.

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	186	197	187
Symptom Distress, Month 6 (n=157, 164, 155)	0.4643 (0.00452)	0.4407 (0.00404)	0.4451 (0.00422)
Symptom Occurrence, Month 6 (n=166, 176, 165)	0.4721 (0.00463)	0.4495 (0.00425)	0.4459 (0.00432)
Symptom Distress, Month 12 (n=169, 185, 169)	0.4751 (0.00453)	0.4510 (0.00397)	0.4546 (0.00421)
Symptom Occurrence, Month 12 (n=173, 188, 173)	0.4776 (0.00458)	0.4519 (0.00411)	0.4525 (0.00430)
Symptom Distress, Month 24 (n=182, 195, 179)	0.4798 (0.00443)	0.4584 (0.00397)	0.4646 (0.00424)
Symptom Occurrence, Month 24 (n=184, 197, 184)	0.4804 (0.00446)	0.4574 (0.00406)	0.4593 (0.00423)
Symptom Distress, Month 36 (n=184, 196, 183)	0.5000 (0.00456)	0.4746 (0.00408)	0.4892 (0.00442)
Symptom Occurrence, Month 36 (n=186, 197, 187)	0.5000 (0.00459)	0.4732 (0.00421)	0.4846 (0.00441)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.024
	Confidence Interval	(2-Sided) 95%; -0.032 to -0.015
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.019
	Confidence Interval	(2-Sided) 95%; -0.028 to -0.011
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Symptom Occurrence, Month 6.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.023
	Confidence Interval	(2-Sided) 95%; -0.031 to -0.014
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Symptom Occurrence, Month 6.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.026
	Confidence Interval	(2-Sided) 95%; -0.035 to -0.017
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.024
	Confidence Interval	(2-Sided) 95%; -0.032 to -0.016
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.020
	Confidence Interval	(2-Sided) 95%; -0.029 to -0.012
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Symptom Occurrence, Month 12.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.026
	Confidence Interval	(2-Sided) 95%; -0.034 to -0.017
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Symptom Occurrence, Month 12.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.025
	Confidence Interval	(2-Sided) 95%; -0.034 to -0.016
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.021
	Confidence Interval	(2-Sided) 95%; -0.030 to -0.013
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 95%; -0.024 to -0.007
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Symptom Occurrence, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.023
	Confidence Interval	(2-Sided) 95%; -0.031 to -0.015
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Symptom Occurrence, Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.
	Method	z-test
	Comments	The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	-0.021
	Confidence Interval	(2-Sided) 95%; -0.030 to -0.013
	Parameter Dispersion	Type: Value:
	Estimation Comments

40. Secondary Outcome

Title	Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36
Description	SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time Frame	Baseline to Months 6, 12, 24,and 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	192	203	193
Mental Component Score; Month 6 (n=187, 197, 184)	5.4 (0.714)	6.2 (0.695)	7.3 (0.720)
Physical Component Score; Month 6 (n=187, 197, 184	5.0 (0.580)	6.2 (0.566)	6.7 (0.585)
Mental Component Score; Month 12 (n=192, 200, 189)	5.4 (0.687)	6.8 (0.673)	6.2 (0.693)
Physical Component Score; Month 12 (n=192,200,189)	5.5 (0.589)	7.1 (0.577)	7.8 (0.594)
Mental Component Score; Month 24 (n=191,202,193)	4.4 (0.732)	5.7 (0.712)	5.1 (0.728)
Physical Component Score; Month 24 (n=191,202,193)	5.1 (0.601)	6.5 (0.584)	7.3 (0.597)
Mental Component Score; Month 36 (n=190,203,191)	2.6 (0.756)	5.1 (0.732)	4.5 (0.754)
Physical Component Score; Month 36 (n=190,203,191)	4.9 (0.633)	6.5 (0.612)	6.1 (0.631)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4498
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.2 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0584
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.1 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1595
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0457
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.0 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1729
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.6 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4209
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.1 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0526
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -0.0 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0077
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 0.6 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1849
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -0.6 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4633
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.3 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0971
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -0.3 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0102
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 0.5 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Mental Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0186
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 0.4 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Mental Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0775
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.2 to 4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Physical Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0768
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -0.2 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Physical Component Score; Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1876
	Comments
	Method	ANCOVA
	Comments	Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Value)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.6 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.

41. Secondary Outcome

Title	Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36
Description	SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.
Time Frame	Baseline to Months 6, 12, 24, and 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	194	207	197
Bodily Pain, Month 6 (n=189,201,189)	2.9 (0.712)	4.5 (0.691)	4.6 (0.712)
General Health, Month 6 (n=189,201,190)	6.7 (0.631)	7.1 (0.612)	7.3 (0.630)
Mental Health, Month 6 (n=188,198,190)	4.7 (0.716)	5.2 (0.698)	6.1 (0.712)
Physical Functioning, Month 6 (n=189,201,190)	4.7 (0.610)	5.3 (0.592)	5.6 (0.610)
Role Emotional, Month 6 (n=188,200,186)	4.7 (0.767)	5.8 (0.744)	6.9 (0.772)
Role-Physical, Month 6 (n=188,201,187)	6.4 (0.718)	8.4 (0.694)	9.6 (0.720)
Social Functioning, Month 6 (n=189,201,190)	6.0 (0.724)	6.8 (0.702)	6.9 (0.722)
Vitality, Month 6 (n=188,198,190)	7.5 (0.668)	9.0 (0.651)	9.9 (0.665)
Bodily Pain, Month 12 (n=194,205,195)	3.1 (0.665)	4.8 (0.647)	5.5 (0.664)
General Health, Month 12 (n=194,206,195)	6.0 (0.638)	7.7 (0.619)	7.6 (0.636)
Mental Health, Month 12 (n=194,203,195)	4.4 (0.685)	6.0 (0.670)	5.0 (0.684)
Physical Functioning, Month 12 (n=194,206,194)	4.7 (0.640)	6.2 (0.621)	5.8 (0.641)
Role Emotional, Month 12 (n=192,205,191)	5.7 (0.765)	6.6 (0.741)	5.9 (0.768)
Role-Physical, Month 12 (n=193,205,191)	8.3 (0.716)	10.3 (0.695)	10.4 (0.720)
Social Functioning, Month 12 (n=194,205,195)	6.4 (0.669)	7.7 (0.650)	8.0 (0.667)
Vitality, Month 12 (n=194,203,195)	7.0 (0.651)	9.2 (0.636)	9.7 (0.649)
Bodily Pain, Month 24 (n=192,207,197)	3.2 (0.722)	3.3 (0.696)	4.1 (0.713)
General Health, Month 24 (n=193,207,197)	5.1 (0.641)	7.2 (0.619)	6.8 (0.635)
Mental Health, Month 24 (n=193,203,195)	3.2 (0.710)	4.6 (0.692)	4.0 (0.706)
Physical Functioning, Month 24 (n=193,207,197)	4.1 (0.685)	5.7 (0.662)	5.5 (0.679)
Role Emotional, Month 24 (n=192,206,196)	4.7 (0.793)	6.0 (0.766)	5.9 (0.785)
Role-Physical, Month 24 (n=193,207,195)	7.4 (0.740)	9.4 (0.715)	10.7 (0.737)
Social Functioning, Month 24 (n=193, 207,197)	5.9 (0.722)	7.4 (0.697)	6.3 (0.715)
Vitality, Month 24 (n=193,203,196)	6.2 (0.700)	7.9 (0.682)	8.0 (0.695)
Bodily Pain, Month 36 (n=191,207,196)	2.3 (0.739)	4.2 (0.710)	3.0 (0.730)
General Health, Month 36 (n=193,207,197)	4.1 (0.681)	6.6 (0.657)	5.8 (0.674)
Mental Health, Month 36 (n=191,204,195)	1.8 (0.754)	4.1 (0.729)	3.4 (0.746)
Physical Functioning, Month 36 (n=192,206,197)	4.4 (0.692)	5.3 (0.668)	5.1 (0.684)
Role Emotional, Month 36 (n=192,207,195)	3.3 (0.830)	5.6 (0.800)	5.0 (0.824)
Role-Physical, Month 36 (n=192,207,195)	6.8 (0.754)	9.2 (0.727)	8.9 (0.749)
Social Functioning, Month 36 (n=192,207,197)	5.1 (0.736)	7.0 (0.708)	5.6 (0.726)
Vitality, Month 36 (n=191,204,195)	4.9 (0.721)	7.3 (0.698)	7.3 (0.714)

42. Secondary Outcome

Title	Percent of Participants Surviving With a Functioning Graft
Description	Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.
Time Frame	Months 24, 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N>=5. Otherwise exact method is used.

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Month 24	90.5 41%	94.7 41.9%	94.1 43%
Month 36	88.7 40.1%	92.0 40.7%	92.2 42.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 24
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 97.3%; -1.3 to 10.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 24
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 97.3%; -2.2 to 9.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 36
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 97.3%; -2.9 to 9.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 97.3%; -2.8 to 10.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

43. Secondary Outcome

Title	Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36
Description	Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.
Time Frame	Randomization to Month 36

Outcome Measure Data

Analysis Population Description

All randomized and transplanted participants, intent to treat (ITT) population

Arm/Group Title	Cyclosporine	Belatacept LI	Belatacept MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Measure Participants	221	226	219
Month 12	13.6 6.2%	19.5 8.6%	25.1 11.5%
Month 24	18.1 8.2%	19.9 8.8%	27.9 12.7%
Month 36	19.9 9%	20.8 9.2%	28.3 12.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95%; -1.0 to 12.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	11.5
	Confidence Interval	(2-Sided) 95%; 4.2 to 18.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -5.5 to 9.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	9.8
	Confidence Interval	(2-Sided) 95%; 1.9 to 17.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept LI
	Comments	Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -6.6 to 8.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cyclosporine, Belatacept MI
	Comments	Month 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	8.4
	Confidence Interval	(2-Sided) 95%; 0.4 to 16.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Randomization to Long Term Extension, up to 84 Months
Adverse Event Reporting Description	Study start: March 2005; Study Completion: April 2015. All randomized, transplanted, and treated participants (ITT population)
Arm/Group Title	Cyclosporine		Belatacept - LI		Belatacept - MI
Arm/Group Description	Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)		Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)		Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
All Cause Mortality
	Cyclosporine		Belatacept - LI		Belatacept - MI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cyclosporine		Belatacept - LI		Belatacept - MI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	167/215 (77.7%)		160/226 (70.8%)		164/219 (74.9%)
Blood and lymphatic system disorders
Agranulocytosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Leukopenia	4/215 (1.9%)		1/226 (0.4%)		4/219 (1.8%)
Pancytopenia	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Haemolytic uraemic syndrome	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Anaemia	7/215 (3.3%)		4/226 (1.8%)		7/219 (3.2%)
Bicytopenia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Febrile neutropenia	1/215 (0.5%)		1/226 (0.4%)		2/219 (0.9%)
Neutropenia	1/215 (0.5%)		3/226 (1.3%)		4/219 (1.8%)
Splenic cyst	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Aplasia pure red cell	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Coagulopathy	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Lymphadenopathy	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Thrombocytopenia	0/215 (0%)		1/226 (0.4%)		4/219 (1.8%)
Cardiac disorders
Acute coronary syndrome	1/215 (0.5%)		2/226 (0.9%)		0/219 (0%)
Angina pectoris	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Atrial fibrillation	2/215 (0.9%)		1/226 (0.4%)		3/219 (1.4%)
Cardiogenic shock	0/215 (0%)		1/226 (0.4%)		2/219 (0.9%)
Mitral valve disease	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bradycardia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cardiac failure	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Left ventricular dysfunction	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Tachycardia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Ventricular fibrillation	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Angina unstable	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Aortic valve disease	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cardiac arrest	8/215 (3.7%)		2/226 (0.9%)		3/219 (1.4%)
Myocardial infarction	5/215 (2.3%)		1/226 (0.4%)		4/219 (1.8%)
Myocardial ischaemia	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Coronary artery disease	2/215 (0.9%)		0/226 (0%)		1/219 (0.5%)
Pericardial effusion	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pulseless electrical activity	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Atrial flutter	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Acute myocardial infarction	1/215 (0.5%)		5/226 (2.2%)		6/219 (2.7%)
Cardiac failure congestive	3/215 (1.4%)		1/226 (0.4%)		0/219 (0%)
Ischaemic cardiomyopathy	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Arrhythmia	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Supraventricular tachycardia	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Congenital, familial and genetic disorders
Congenital cystic kidney disease	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Polycystic liver disease	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Patent ductus arteriosus	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Ear and labyrinth disorders
Vertigo	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Deafness	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Motion sickness	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Middle ear effusion	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Endocrine disorders
Hyperparathyroidism	5/215 (2.3%)		2/226 (0.9%)		2/219 (0.9%)
Hyperparathyroidism tertiary	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Eye disorders
Retinal vein occlusion	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Papilloedema	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Vision blurred	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Vitreous haemorrhage	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Gastrointestinal disorders
Ascites	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Diabetic gastroparesis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Gastritis erosive	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Gastrooesophageal reflux disease	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hernial eventration	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Inguinal hernia	1/215 (0.5%)		0/226 (0%)		2/219 (0.9%)
Melaena	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Nausea	2/215 (0.9%)		1/226 (0.4%)		1/219 (0.5%)
Tongue ulceration	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Vomiting	3/215 (1.4%)		2/226 (0.9%)		3/219 (1.4%)
Enteritis	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Gastrointestinal haemorrhage	0/215 (0%)		0/226 (0%)		5/219 (2.3%)
Umbilical hernia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Colitis	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Constipation	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Food poisoning	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Ileus	3/215 (1.4%)		0/226 (0%)		0/219 (0%)
Intestinal obstruction	0/215 (0%)		3/226 (1.3%)		0/219 (0%)
Pancreatolithiasis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Volvulus	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Abdominal hernia	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Abdominal pain	8/215 (3.7%)		1/226 (0.4%)		3/219 (1.4%)
Abdominal pain lower	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Diarrhoea	9/215 (4.2%)		12/226 (5.3%)		9/219 (4.1%)
Incarcerated inguinal hernia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Intestinal haemorrhage	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Gastrointestinal disorder	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Intestinal perforation	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Large intestine perforation	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Large intestine polyp	2/215 (0.9%)		0/226 (0%)		1/219 (0.5%)
Retroperitoneal haematoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Gastric ulcer perforation	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Hiatus hernia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Ileus paralytic	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Irritable bowel syndrome	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pancreatitis	1/215 (0.5%)		0/226 (0%)		2/219 (0.9%)
Pancreatitis acute	1/215 (0.5%)		1/226 (0.4%)		3/219 (1.4%)
Rectal haemorrhage	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Thrombosis mesenteric vessel	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Abdominal compartment syndrome	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Colitis ischaemic	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Gastritis	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Intra-abdominal haemorrhage	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Mesenteric arterial occlusion	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Small intestinal obstruction	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Toothache	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
General disorders
Hyperthermia	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pneumatosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Ulcer	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Accidental death	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hernia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Oedema peripheral	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Sudden death	1/215 (0.5%)		2/226 (0.9%)		2/219 (0.9%)
Incarcerated hernia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Malaise	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pyrexia	16/215 (7.4%)		17/226 (7.5%)		13/219 (5.9%)
Chest discomfort	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Asthenia	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Chest pain	6/215 (2.8%)		3/226 (1.3%)		6/219 (2.7%)
General physical health deterioration	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Inflammation	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Multi-organ failure	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Peripheral swelling	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Influenza like illness	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Ischaemic ulcer	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Systemic inflammatory response syndrome	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hepatobiliary disorders
Biliary colic	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Cholelithiasis	5/215 (2.3%)		0/226 (0%)		2/219 (0.9%)
Hepatitis alcoholic	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bile duct obstruction	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Cholecystitis acute	1/215 (0.5%)		2/226 (0.9%)		0/219 (0%)
Hepatic function abnormal	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hepatosplenomegaly	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cholangitis	2/215 (0.9%)		1/226 (0.4%)		1/219 (0.5%)
Cholecystitis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Gallbladder disorder	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Bile duct stenosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Bile duct stone	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hepatic cirrhosis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hepatitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Immune system disorders
Transplant rejection	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Drug hypersensitivity	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Renal transplant failure	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Chronic allograft nephropathy	4/215 (1.9%)		4/226 (1.8%)		4/219 (1.8%)
Infections and infestations
Abdominal sepsis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Acinetobacter infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Arteriovenous graft site infection	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Bacteraemia	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Encephalitis meningococcal	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Furuncle	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Hepatitis E	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Histoplasmosis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Lower respiratory tract infection	2/215 (0.9%)		1/226 (0.4%)		3/219 (1.4%)
Periodontitis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Postoperative wound infection	1/215 (0.5%)		1/226 (0.4%)		2/219 (0.9%)
Pyelonephritis acute	2/215 (0.9%)		4/226 (1.8%)		6/219 (2.7%)
Subcutaneous abscess	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Tuberculosis	0/215 (0%)		1/226 (0.4%)		3/219 (1.4%)
Tuberculosis gastrointestinal	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Tuberculosis of intrathoracic lymph nodes	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Urinary tract infection enterococcal	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Varicella zoster virus infection	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Vulval abscess	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Arthritis bacterial	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bone tuberculosis	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Campylobacter gastroenteritis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Cellulitis	4/215 (1.9%)		4/226 (1.8%)		3/219 (1.4%)
Erysipelas	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Fungal skin infection	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Gastroenteritis	7/215 (3.3%)		4/226 (1.8%)		9/219 (4.1%)
Gastroenteritis viral	3/215 (1.4%)		2/226 (0.9%)		1/219 (0.5%)
H1N1 influenza	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Meningitis cryptococcal	0/215 (0%)		1/226 (0.4%)		2/219 (0.9%)
Oesophageal candidiasis	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Pulmonary tuberculosis	2/215 (0.9%)		1/226 (0.4%)		2/219 (0.9%)
Staphylococcal sepsis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Streptococcal urinary tract infection	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Tubo-ovarian abscess	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Abdominal abscess	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Arteriovenous fistula site infection	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Atypical pneumonia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Blastomycosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cytomegalovirus gastrointestinal infection	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Folliculitis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Localised infection	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Lymph node tuberculosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Oral herpes	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Osteomyelitis	1/215 (0.5%)		1/226 (0.4%)		2/219 (0.9%)
Ovarian abscess	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pharyngotonsillitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Progressive multifocal leukoencephalopathy	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pseudomonas infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Psoas abscess	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Sepsis	8/215 (3.7%)		6/226 (2.7%)		9/219 (4.1%)
West Nile viral infection	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Abdominal wall abscess	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bronchitis	3/215 (1.4%)		0/226 (0%)		1/219 (0.5%)
Diabetic foot infection	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Endocarditis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Herpes zoster	2/215 (0.9%)		2/226 (0.9%)		2/219 (0.9%)
Labyrinthitis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Malaria	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Peritonitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Pneumonia influenzal	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Polyomavirus-associated nephropathy	1/215 (0.5%)		3/226 (1.3%)		2/219 (0.9%)
Septic shock	3/215 (1.4%)		2/226 (0.9%)		2/219 (0.9%)
Sinusitis	0/215 (0%)		2/226 (0.9%)		4/219 (1.8%)
Soft tissue infection	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Staphylococcal bacteraemia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Upper respiratory tract infection	5/215 (2.3%)		2/226 (0.9%)		1/219 (0.5%)
Abscess	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Appendicitis	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Cholecystitis infective	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cytomegalovirus colitis	0/215 (0%)		2/226 (0.9%)		1/219 (0.5%)
Parvovirus infection	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Pharyngitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Pneumocystis jirovecii pneumonia	2/215 (0.9%)		2/226 (0.9%)		2/219 (0.9%)
Respiratory tract infection	3/215 (1.4%)		3/226 (1.3%)		2/219 (0.9%)
Tooth abscess	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Varicella	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Anal abscess	1/215 (0.5%)		1/226 (0.4%)		2/219 (0.9%)
Bacterial infection	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Candida infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Clostridium difficile colitis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Cryptococcosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cytomegalovirus hepatitis	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Diverticulitis	0/215 (0%)		1/226 (0.4%)		2/219 (0.9%)
Escherichia urinary tract infection	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Gangrene	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Groin abscess	1/215 (0.5%)		1/226 (0.4%)		2/219 (0.9%)
Hepatic cyst infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Influenza	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Necrotising fasciitis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Peritonitis bacterial	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pneumonia	17/215 (7.9%)		14/226 (6.2%)		9/219 (4.1%)
Strongyloidiasis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Urinary tract infection	32/215 (14.9%)		26/226 (11.5%)		21/219 (9.6%)
Urinary tract infection bacterial	3/215 (1.4%)		0/226 (0%)		0/219 (0%)
Bronchiolitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bursitis infective	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Cytomegalovirus viraemia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Gastrointestinal viral infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Oral candidiasis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Parasitic encephalitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Pneumonia bacterial	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pyelonephritis	9/215 (4.2%)		9/226 (4%)		8/219 (3.7%)
Pyelonephritis viral	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Staphylococcal infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Streptococcal sepsis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Wound sepsis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
BK virus infection	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Bacterial diarrhoea	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bacterial pyelonephritis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Bronchopulmonary aspergillosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Chest wall abscess	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Clostridium difficile infection	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Cytomegalovirus duodenitis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Cytomegalovirus enteritis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Cytomegalovirus gastroenteritis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Cytomegalovirus infection	8/215 (3.7%)		13/226 (5.8%)		16/219 (7.3%)
Device related infection	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Epididymitis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Escherichia infection	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Gastroenteritis norovirus	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Infected skin ulcer	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Infection	0/215 (0%)		2/226 (0.9%)		2/219 (0.9%)
Orchitis	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Pertussis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pneumonia cytomegaloviral	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Pneumonia legionella	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Sepsis syndrome	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Sialoadenitis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Tuberculous pleurisy	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Urosepsis	4/215 (1.9%)		2/226 (0.9%)		3/219 (1.4%)
Viral infection	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Wound infection	2/215 (0.9%)		4/226 (1.8%)		1/219 (0.5%)
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis	3/215 (1.4%)		1/226 (0.4%)		1/219 (0.5%)
Delayed graft function	9/215 (4.2%)		3/226 (1.3%)		2/219 (0.9%)
Limb injury	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Multiple fractures	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Postoperative wound complication	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Renal lymphocele	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Rib fracture	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Soft tissue injury	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Transplant dysfunction	7/215 (3.3%)		5/226 (2.2%)		3/219 (1.4%)
Transplant failure	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Upper limb fracture	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Ureteric anastomosis complication	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Face injury	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Fall	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Graft complication	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Hip fracture	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Overdose	0/215 (0%)		7/226 (3.1%)		4/219 (1.8%)
Post procedural haematuria	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Road traffic accident	1/215 (0.5%)		1/226 (0.4%)		3/219 (1.4%)
Wound	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Arteriovenous fistula aneurysm	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Chest injury	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Clavicle fracture	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Patella fracture	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Ankle fracture	0/215 (0%)		3/226 (1.3%)		1/219 (0.5%)
Complications of transplanted kidney	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Transfusion reaction	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Wound dehiscence	0/215 (0%)		3/226 (1.3%)		2/219 (0.9%)
Craniocerebral injury	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Tendon rupture	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Wound evisceration	2/215 (0.9%)		2/226 (0.9%)		1/219 (0.5%)
Complications of transplant surgery	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Excoriation	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Infusion related reaction	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Laceration	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Post procedural haematoma	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Post procedural inflammation	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Seroma	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Urinary anastomotic leak	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Vascular graft complication	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Arteriovenous fistula occlusion	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Post procedural haemorrhage	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Stenosis of vesicourethral anastomosis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Carbon monoxide poisoning	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Graft loss	2/215 (0.9%)		4/226 (1.8%)		2/219 (0.9%)
Humerus fracture	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Lower limb fracture	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Post procedural complication	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Postoperative ileus	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Procedural hypotension	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Subdural haematoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Tibia fracture	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Toxicity to various agents	9/215 (4.2%)		2/226 (0.9%)		0/219 (0%)
Investigations
Blood glucose fluctuation	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Liver function test abnormal	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Blood creatine increased	1/215 (0.5%)		2/226 (0.9%)		1/219 (0.5%)
Blood culture positive	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cytomegalovirus test positive	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Polyomavirus test positive	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Platelet count decreased	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
C-reactive protein increased	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hepatic enzyme increased	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Pneumocystis test positive	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Ultrasound kidney abnormal	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Weight decreased	0/215 (0%)		4/226 (1.8%)		2/219 (0.9%)
Blood glucose decreased	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Coagulation test abnormal	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Blood creatinine increased	16/215 (7.4%)		10/226 (4.4%)		5/219 (2.3%)
Staphylococcus test positive	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Metabolism and nutrition disorders
Hyperkalaemia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Hypocalcaemia	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Hypoglycaemia	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Hypokalaemia	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Hyponatraemia	5/215 (2.3%)		0/226 (0%)		0/219 (0%)
Malnutrition	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Metabolic acidosis	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Type 2 diabetes mellitus	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Acidosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Failure to thrive	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hyperglycaemia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Hypomagnesaemia	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Dehydration	6/215 (2.8%)		2/226 (0.9%)		5/219 (2.3%)
Fluid overload	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Diabetes mellitus inadequate control	1/215 (0.5%)		0/226 (0%)		2/219 (0.9%)
Gout	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hypovolaemia	3/215 (1.4%)		2/226 (0.9%)		1/219 (0.5%)
Diabetes mellitus	4/215 (1.9%)		1/226 (0.4%)		2/219 (0.9%)
Diabetic ketoacidosis	1/215 (0.5%)		3/226 (1.3%)		0/219 (0%)
Electrolyte imbalance	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hypercalcaemia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Musculoskeletal and connective tissue disorders
Groin pain	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Osteonecrosis	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Osteoarthritis	1/215 (0.5%)		2/226 (0.9%)		2/219 (0.9%)
Musculoskeletal chest pain	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Bursitis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Diastasis recti abdominis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Neuropathic arthropathy	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Lip squamous cell carcinoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Metastases to lung	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Metastatic uterine cancer	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Prostate cancer	3/215 (1.4%)		1/226 (0.4%)		1/219 (0.5%)
Renal oncocytoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Thyroid cancer	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Anogenital warts	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Brain neoplasm	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Iris neoplasm	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Lung neoplasm malignant	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Pancreatic neoplasm	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Sarcoma	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Throat cancer	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Adenoma benign	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Basal cell carcinoma	12/215 (5.6%)		9/226 (4%)		8/219 (3.7%)
Basosquamous carcinoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Malignant melanoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Metastatic malignant melanoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Breast cancer	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Hepatic adenoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Lung cancer metastatic	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Post transplant lymphoproliferative disorder	2/215 (0.9%)		1/226 (0.4%)		2/219 (0.9%)
Skin cancer	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Uterine leiomyoma	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Acanthoma	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Benign breast neoplasm	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Bladder adenocarcinoma stage unspecified	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Chronic myeloid leukaemia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Invasive ductal breast carcinoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Renal cancer	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Squamous cell carcinoma of lung	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Squamous cell carcinoma of skin	9/215 (4.2%)		8/226 (3.5%)		9/219 (4.1%)
Thymic cancer metastatic	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Metastatic squamous cell carcinoma	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Non-small cell lung cancer	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Oesophageal carcinoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Squamous cell carcinoma	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
B-cell lymphoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cervix carcinoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Haemangioma of liver	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Keratoacanthoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Malignant pleural effusion	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Papillary thyroid cancer	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Parathyroid tumour benign	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Bladder papilloma	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Bowen's disease	2/215 (0.9%)		0/226 (0%)		3/219 (1.4%)
Lymphoma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Renal cell carcinoma	0/215 (0%)		2/226 (0.9%)		1/219 (0.5%)
Renal neoplasm	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Nervous system disorders
Headache	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Spinal cord compression	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Hypoaesthesia	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Loss of consciousness	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Presyncope	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Generalised tonic-clonic seizure	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Haemorrhage intracranial	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Sciatica	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Amnesia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Intracranial pressure increased	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Carotid artery stenosis	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Central nervous system lesion	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Cerebrovascular accident	2/215 (0.9%)		2/226 (0.9%)		5/219 (2.3%)
Migraine	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pineal gland cyst	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Syncope	3/215 (1.4%)		1/226 (0.4%)		0/219 (0%)
Action tremor	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hemiparesis	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Myasthenic syndrome	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Seizure	1/215 (0.5%)		2/226 (0.9%)		1/219 (0.5%)
Cerebral haematoma	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Cervicobrachial syndrome	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Mononeuropathy	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Transient ischaemic attack	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Psychiatric disorders
Mania	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Suicidal ideation	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Acute psychosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Delirium	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Mental status changes	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Completed suicide	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hallucination	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Panic attack	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Mental disorder	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Anxiety	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Hypomania	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Alcoholism	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Renal and urinary disorders
Acute kidney injury	13/215 (6%)		4/226 (1.8%)		6/219 (2.7%)
Renal artery thrombosis	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Ureteric obstruction	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Chronic kidney disease	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Glomerulonephritis acute	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Haematuria	2/215 (0.9%)		1/226 (0.4%)		3/219 (1.4%)
Renal impairment	6/215 (2.8%)		7/226 (3.1%)		5/219 (2.3%)
Renal tubular disorder	2/215 (0.9%)		1/226 (0.4%)		1/219 (0.5%)
Tubulointerstitial nephritis	2/215 (0.9%)		0/226 (0%)		1/219 (0.5%)
Azotaemia	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Calculus urinary	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Obstructive uropathy	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Renal cyst	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Renal haematoma	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Ureteric stenosis	5/215 (2.3%)		2/226 (0.9%)		0/219 (0%)
Vesicoureteric reflux	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Nephritis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Renal artery stenosis	2/215 (0.9%)		2/226 (0.9%)		3/219 (1.4%)
Renal mass	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Renal tubular necrosis	4/215 (1.9%)		1/226 (0.4%)		2/219 (0.9%)
Urinary incontinence	1/215 (0.5%)		4/226 (1.8%)		3/219 (1.4%)
Acute prerenal failure	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Glomerulonephritis membranous	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hydronephrosis	4/215 (1.9%)		0/226 (0%)		4/219 (1.8%)
Renal cyst ruptured	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Renal vein thrombosis	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Urinary bladder polyp	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Urinary retention	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Ureteric haemorrhage	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Focal segmental glomerulosclerosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Proteinuria	3/215 (1.4%)		1/226 (0.4%)		1/219 (0.5%)
Renal haemorrhage	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Renal tubular atrophy	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Urinary fistula	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Urinary tract obstruction	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Urinoma	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Anuria	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Bladder neck sclerosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Nephrolithiasis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Nephropathy	1/215 (0.5%)		2/226 (0.9%)		0/219 (0%)
Renal failure	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Ureteral necrosis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Urinary bladder haemorrhage	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Reproductive system and breast disorders
Acquired hydrocele	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Prostatitis	3/215 (1.4%)		1/226 (0.4%)		1/219 (0.5%)
Vaginal haemorrhage	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Menorrhagia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Breast calcifications	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Priapism	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Uterine polyp	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Metrorrhagia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Benign prostatic hyperplasia	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Endometriosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pneumonitis	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Pneumothorax	1/215 (0.5%)		2/226 (0.9%)		1/219 (0.5%)
Asthma	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Laryngeal oedema	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Respiratory arrest	1/215 (0.5%)		1/226 (0.4%)		1/219 (0.5%)
Sleep apnoea syndrome	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Acute respiratory distress syndrome	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Bronchitis chronic	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Chronic obstructive pulmonary disease	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Hypoxia	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Interstitial lung disease	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Lung disorder	1/215 (0.5%)		2/226 (0.9%)		3/219 (1.4%)
Pulmonary embolism	1/215 (0.5%)		1/226 (0.4%)		2/219 (0.9%)
Dyspnoea	2/215 (0.9%)		2/226 (0.9%)		2/219 (0.9%)
Pulmonary hypertension	0/215 (0%)		1/226 (0.4%)		2/219 (0.9%)
Pulmonary oedema	2/215 (0.9%)		1/226 (0.4%)		1/219 (0.5%)
Respiratory distress	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Respiratory failure	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Acute pulmonary oedema	2/215 (0.9%)		4/226 (1.8%)		0/219 (0%)
Atelectasis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Pleural effusion	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pulmonary congestion	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Acute respiratory failure	1/215 (0.5%)		0/226 (0%)		1/219 (0.5%)
Bullous lung disease	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Skin and subcutaneous tissue disorders
Skin ulcer	0/215 (0%)		1/226 (0.4%)		3/219 (1.4%)
Ingrowing nail	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pruritus	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Rash generalised	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Subcutaneous emphysema	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Actinic keratosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Erythema multiforme	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Vascular disorders
Femoral artery occlusion	0/215 (0%)		0/226 (0%)		2/219 (0.9%)
Haematoma	2/215 (0.9%)		2/226 (0.9%)		2/219 (0.9%)
Hypertension	4/215 (1.9%)		2/226 (0.9%)		3/219 (1.4%)
Infarction	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Arterial stenosis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Lymphocele	8/215 (3.7%)		2/226 (0.9%)		2/219 (0.9%)
Peripheral vascular disorder	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Arterial thrombosis	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Embolism venous	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Pelvic venous thrombosis	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Peripheral artery dissection	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Peripheral artery stenosis	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Peripheral ischaemia	1/215 (0.5%)		2/226 (0.9%)		1/219 (0.5%)
Thrombosis	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Vascular compression	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Deep vein thrombosis	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Hypertensive emergency	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Ischaemia	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Phlebitis superficial	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Shock haemorrhagic	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Capillary leak syndrome	0/215 (0%)		1/226 (0.4%)		0/219 (0%)
Hypertensive crisis	2/215 (0.9%)		1/226 (0.4%)		0/219 (0%)
Orthostatic hypotension	0/215 (0%)		0/226 (0%)		1/219 (0.5%)
Peripheral arterial occlusive disease	0/215 (0%)		2/226 (0.9%)		0/219 (0%)
Peripheral artery thrombosis	0/215 (0%)		1/226 (0.4%)		1/219 (0.5%)
Thrombophlebitis superficial	1/215 (0.5%)		1/226 (0.4%)		0/219 (0%)
Arterial occlusive disease	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Hypotension	4/215 (1.9%)		2/226 (0.9%)		5/219 (2.3%)
Thrombophlebitis	2/215 (0.9%)		0/226 (0%)		0/219 (0%)
Aortic stenosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Extremity necrosis	1/215 (0.5%)		0/226 (0%)		0/219 (0%)
Other (Not Including Serious) Adverse Events
	Cyclosporine		Belatacept - LI		Belatacept - MI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	213/215 (99.1%)		222/226 (98.2%)		216/219 (98.6%)
Blood and lymphatic system disorders
Leukopenia	37/215 (17.2%)		48/226 (21.2%)		40/219 (18.3%)
Polycythaemia	11/215 (5.1%)		17/226 (7.5%)		14/219 (6.4%)
Anaemia	86/215 (40%)		92/226 (40.7%)		85/219 (38.8%)
Leukocytosis	9/215 (4.2%)		16/226 (7.1%)		10/219 (4.6%)
Neutropenia	10/215 (4.7%)		14/226 (6.2%)		9/219 (4.1%)
Thrombocytopenia	20/215 (9.3%)		9/226 (4%)		16/219 (7.3%)
Cardiac disorders
Bradycardia	13/215 (6%)		9/226 (4%)		8/219 (3.7%)
Tachycardia	23/215 (10.7%)		12/226 (5.3%)		19/219 (8.7%)
Ear and labyrinth disorders
Tinnitus	7/215 (3.3%)		12/226 (5.3%)		5/219 (2.3%)
Ear pain	3/215 (1.4%)		13/226 (5.8%)		5/219 (2.3%)
Eye disorders
Cataract	11/215 (5.1%)		7/226 (3.1%)		10/219 (4.6%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	13/215 (6%)		19/226 (8.4%)		11/219 (5%)
Nausea	70/215 (32.6%)		62/226 (27.4%)		59/219 (26.9%)
Vomiting	46/215 (21.4%)		55/226 (24.3%)		45/219 (20.5%)
Flatulence	11/215 (5.1%)		16/226 (7.1%)		9/219 (4.1%)
Gingival hyperplasia	18/215 (8.4%)		0/226 (0%)		2/219 (0.9%)
Abdominal discomfort	11/215 (5.1%)		7/226 (3.1%)		8/219 (3.7%)
Abdominal pain upper	24/215 (11.2%)		22/226 (9.7%)		19/219 (8.7%)
Constipation	68/215 (31.6%)		83/226 (36.7%)		65/219 (29.7%)
Dyspepsia	26/215 (12.1%)		35/226 (15.5%)		20/219 (9.1%)
Abdominal pain	40/215 (18.6%)		48/226 (21.2%)		47/219 (21.5%)
Abdominal pain lower	6/215 (2.8%)		13/226 (5.8%)		13/219 (5.9%)
Diarrhoea	92/215 (42.8%)		115/226 (50.9%)		118/219 (53.9%)
Haemorrhoids	15/215 (7%)		19/226 (8.4%)		14/219 (6.4%)
Mouth ulceration	3/215 (1.4%)		7/226 (3.1%)		11/219 (5%)
Abdominal distension	17/215 (7.9%)		15/226 (6.6%)		16/219 (7.3%)
Aphthous ulcer	5/215 (2.3%)		16/226 (7.1%)		13/219 (5.9%)
Gastritis	12/215 (5.6%)		14/226 (6.2%)		11/219 (5%)
General disorders
Oedema	25/215 (11.6%)		11/226 (4.9%)		13/219 (5.9%)
Chills	10/215 (4.7%)		15/226 (6.6%)		9/219 (4.1%)
Oedema peripheral	87/215 (40.5%)		70/226 (31%)		64/219 (29.2%)
Pain	14/215 (6.5%)		14/226 (6.2%)		20/219 (9.1%)
Pyrexia	56/215 (26%)		68/226 (30.1%)		61/219 (27.9%)
Asthenia	21/215 (9.8%)		27/226 (11.9%)		16/219 (7.3%)
Chest pain	21/215 (9.8%)		17/226 (7.5%)		22/219 (10%)
Fatigue	32/215 (14.9%)		27/226 (11.9%)		22/219 (10%)
Peripheral swelling	9/215 (4.2%)		8/226 (3.5%)		12/219 (5.5%)
Immune system disorders
Chronic allograft nephropathy	21/215 (9.8%)		4/226 (1.8%)		5/219 (2.3%)
Infections and infestations
Fungal skin infection	9/215 (4.2%)		16/226 (7.1%)		10/219 (4.6%)
Gastroenteritis	20/215 (9.3%)		19/226 (8.4%)		25/219 (11.4%)
Conjunctivitis	9/215 (4.2%)		11/226 (4.9%)		12/219 (5.5%)
Onychomycosis	10/215 (4.7%)		16/226 (7.1%)		15/219 (6.8%)
Oral herpes	12/215 (5.6%)		22/226 (9.7%)		16/219 (7.3%)
Bronchitis	21/215 (9.8%)		29/226 (12.8%)		22/219 (10%)
Herpes zoster	19/215 (8.8%)		14/226 (6.2%)		20/219 (9.1%)
Sinusitis	18/215 (8.4%)		24/226 (10.6%)		17/219 (7.8%)
Tinea versicolour	15/215 (7%)		11/226 (4.9%)		6/219 (2.7%)
Upper respiratory tract infection	52/215 (24.2%)		56/226 (24.8%)		60/219 (27.4%)
Pharyngitis	18/215 (8.4%)		22/226 (9.7%)		17/219 (7.8%)
Candida infection	4/215 (1.9%)		8/226 (3.5%)		11/219 (5%)
Influenza	27/215 (12.6%)		40/226 (17.7%)		37/219 (16.9%)
Nasopharyngitis	49/215 (22.8%)		39/226 (17.3%)		49/219 (22.4%)
Pneumonia	8/215 (3.7%)		14/226 (6.2%)		11/219 (5%)
Urinary tract infection	77/215 (35.8%)		91/226 (40.3%)		71/219 (32.4%)
Oral candidiasis	14/215 (6.5%)		11/226 (4.9%)		19/219 (8.7%)
BK virus infection	11/215 (5.1%)		9/226 (4%)		13/219 (5.9%)
Cytomegalovirus infection	19/215 (8.8%)		13/226 (5.8%)		10/219 (4.6%)
Injury, poisoning and procedural complications
Delayed graft function	28/215 (13%)		26/226 (11.5%)		22/219 (10%)
Transplant dysfunction	12/215 (5.6%)		7/226 (3.1%)		5/219 (2.3%)
Contusion	8/215 (3.7%)		8/226 (3.5%)		11/219 (5%)
Fall	16/215 (7.4%)		11/226 (4.9%)		10/219 (4.6%)
Incision site pain	38/215 (17.7%)		30/226 (13.3%)		33/219 (15.1%)
Complications of transplanted kidney	13/215 (6%)		10/226 (4.4%)		7/219 (3.2%)
Complications of transplant surgery	9/215 (4.2%)		7/226 (3.1%)		11/219 (5%)
Procedural pain	40/215 (18.6%)		40/226 (17.7%)		41/219 (18.7%)
Ligament sprain	7/215 (3.3%)		4/226 (1.8%)		12/219 (5.5%)
Toxicity to various agents	27/215 (12.6%)		3/226 (1.3%)		2/219 (0.9%)
Investigations
Weight increased	24/215 (11.2%)		24/226 (10.6%)		27/219 (12.3%)
C-reactive protein increased	11/215 (5.1%)		10/226 (4.4%)		12/219 (5.5%)
Weight decreased	8/215 (3.7%)		22/226 (9.7%)		27/219 (12.3%)
Blood creatinine increased	53/215 (24.7%)		25/226 (11.1%)		26/219 (11.9%)
Metabolism and nutrition disorders
Hyperkalaemia	44/215 (20.5%)		41/226 (18.1%)		18/219 (8.2%)
Hypertriglyceridaemia	11/215 (5.1%)		6/226 (2.7%)		15/219 (6.8%)
Hypocalcaemia	25/215 (11.6%)		27/226 (11.9%)		17/219 (7.8%)
Hypoglycaemia	18/215 (8.4%)		15/226 (6.6%)		13/219 (5.9%)
Hypokalaemia	28/215 (13%)		49/226 (21.7%)		48/219 (21.9%)
Hyponatraemia	12/215 (5.6%)		7/226 (3.1%)		6/219 (2.7%)
Metabolic acidosis	19/215 (8.8%)		8/226 (3.5%)		13/219 (5.9%)
Vitamin D deficiency	9/215 (4.2%)		21/226 (9.3%)		17/219 (7.8%)
Hypercholesterolaemia	26/215 (12.1%)		31/226 (13.7%)		34/219 (15.5%)
Hyperglycaemia	42/215 (19.5%)		38/226 (16.8%)		42/219 (19.2%)
Hypomagnesaemia	24/215 (11.2%)		17/226 (7.5%)		18/219 (8.2%)
Dehydration	15/215 (7%)		11/226 (4.9%)		6/219 (2.7%)
Hypophosphataemia	33/215 (15.3%)		51/226 (22.6%)		36/219 (16.4%)
Decreased appetite	13/215 (6%)		23/226 (10.2%)		13/219 (5.9%)
Dyslipidaemia	70/215 (32.6%)		59/226 (26.1%)		62/219 (28.3%)
Gout	11/215 (5.1%)		10/226 (4.4%)		2/219 (0.9%)
Diabetes mellitus	15/215 (7%)		19/226 (8.4%)		23/219 (10.5%)
Hypercalcaemia	13/215 (6%)		16/226 (7.1%)		16/219 (7.3%)
Iron deficiency	8/215 (3.7%)		11/226 (4.9%)		11/219 (5%)
Hyperlipidaemia	20/215 (9.3%)		19/226 (8.4%)		19/219 (8.7%)
Hyperuricaemia	36/215 (16.7%)		11/226 (4.9%)		8/219 (3.7%)
Musculoskeletal and connective tissue disorders
Pain in extremity	33/215 (15.3%)		40/226 (17.7%)		36/219 (16.4%)
Osteoarthritis	7/215 (3.3%)		9/226 (4%)		14/219 (6.4%)
Osteoporosis	6/215 (2.8%)		15/226 (6.6%)		8/219 (3.7%)
Arthralgia	37/215 (17.2%)		54/226 (23.9%)		51/219 (23.3%)
Myalgia	17/215 (7.9%)		27/226 (11.9%)		19/219 (8.7%)
Osteopenia	13/215 (6%)		14/226 (6.2%)		12/219 (5.5%)
Musculoskeletal pain	12/215 (5.6%)		17/226 (7.5%)		17/219 (7.8%)
Back pain	38/215 (17.7%)		44/226 (19.5%)		47/219 (21.5%)
Muscular weakness	14/215 (6.5%)		8/226 (3.5%)		4/219 (1.8%)
Muscle spasms	17/215 (7.9%)		11/226 (4.9%)		16/219 (7.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	15/215 (7%)		9/226 (4%)		14/219 (6.4%)
Nervous system disorders
Headache	46/215 (21.4%)		75/226 (33.2%)		65/219 (29.7%)
Dizziness	32/215 (14.9%)		25/226 (11.1%)		24/219 (11%)
Hypoaesthesia	7/215 (3.3%)		19/226 (8.4%)		12/219 (5.5%)
Paraesthesia	19/215 (8.8%)		18/226 (8%)		7/219 (3.2%)
Tremor	43/215 (20%)		19/226 (8.4%)		19/219 (8.7%)
Psychiatric disorders
Depression	18/215 (8.4%)		17/226 (7.5%)		26/219 (11.9%)
Insomnia	38/215 (17.7%)		39/226 (17.3%)		42/219 (19.2%)
Anxiety	27/215 (12.6%)		26/226 (11.5%)		27/219 (12.3%)
Renal and urinary disorders
Dysuria	34/215 (15.8%)		26/226 (11.5%)		34/219 (15.5%)
Haematuria	41/215 (19.1%)		39/226 (17.3%)		33/219 (15.1%)
Leukocyturia	9/215 (4.2%)		13/226 (5.8%)		6/219 (2.7%)
Renal impairment	14/215 (6.5%)		10/226 (4.4%)		7/219 (3.2%)
Renal tubular necrosis	19/215 (8.8%)		17/226 (7.5%)		20/219 (9.1%)
Proteinuria	30/215 (14%)		41/226 (18.1%)		30/219 (13.7%)
Reproductive system and breast disorders
Erectile dysfunction	14/215 (6.5%)		8/226 (3.5%)		10/219 (4.6%)
Respiratory, thoracic and mediastinal disorders
Productive cough	9/215 (4.2%)		15/226 (6.6%)		10/219 (4.6%)
Cough	57/215 (26.5%)		81/226 (35.8%)		69/219 (31.5%)
Dyspnoea	36/215 (16.7%)		18/226 (8%)		16/219 (7.3%)
Rhinorrhoea	10/215 (4.7%)		13/226 (5.8%)		11/219 (5%)
Oropharyngeal pain	14/215 (6.5%)		28/226 (12.4%)		19/219 (8.7%)
Nasal congestion	4/215 (1.9%)		11/226 (4.9%)		12/219 (5.5%)
Skin and subcutaneous tissue disorders
Skin lesion	15/215 (7%)		22/226 (9.7%)		24/219 (11%)
Acne	31/215 (14.4%)		22/226 (9.7%)		23/219 (10.5%)
Alopecia	8/215 (3.7%)		19/226 (8.4%)		16/219 (7.3%)
Night sweats	6/215 (2.8%)		11/226 (4.9%)		12/219 (5.5%)
Pruritus	17/215 (7.9%)		17/226 (7.5%)		15/219 (6.8%)
Hyperhidrosis	6/215 (2.8%)		12/226 (5.3%)		9/219 (4.1%)
Hypertrichosis	11/215 (5.1%)		0/226 (0%)		4/219 (1.8%)
Rash	15/215 (7%)		22/226 (9.7%)		20/219 (9.1%)
Vascular disorders
Haematoma	16/215 (7.4%)		9/226 (4%)		12/219 (5.5%)
Hypertension	82/215 (38.1%)		87/226 (38.5%)		70/219 (32%)
Hypotension	31/215 (14.4%)		36/226 (15.9%)		45/219 (20.5%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.