Trial Outcomes & Findings for Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant (NCT NCT00114777)
NCT ID: NCT00114777
Last Updated: 2017-07-07
Results Overview
Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
595 participants
Primary outcome timeframe
Month 12 post-transplant
Results posted on
2017-07-07
Participant Flow
595 participants enrolled, 578 randomized. Reasons for non-randomization included 13 subjects no longer met study criteria; 3 discontinued on sponsor's discretion; 1 due to other reason. Of those randomized, 543 were treated. Reasons for non-treatment were not specified.
Participant milestones
| Measure |
Belatacept More Intensive (MI) Regimen
Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months
|
Belatacept Less Intensive (LI) Regimen
Belatacept 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.
|
Cyclosporin A (CsA)
Cyclosporin A 4-10 mg/kg capsules orally in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.
|
|---|---|---|---|
|
Randomization to Month 36
STARTED
|
184
|
175
|
184
|
|
Randomization to Month 36
COMPLETED
|
109
|
114
|
100
|
|
Randomization to Month 36
NOT COMPLETED
|
75
|
61
|
84
|
|
Long-Term Extension to Month 84
STARTED
|
104
|
113
|
87
|
|
Long-Term Extension to Month 84
COMPLETED
|
74
|
84
|
57
|
|
Long-Term Extension to Month 84
NOT COMPLETED
|
30
|
29
|
30
|
Reasons for withdrawal
| Measure |
Belatacept More Intensive (MI) Regimen
Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months
|
Belatacept Less Intensive (LI) Regimen
Belatacept 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.
|
Cyclosporin A (CsA)
Cyclosporin A 4-10 mg/kg capsules orally in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.
|
|---|---|---|---|
|
Randomization to Month 36
Death
|
10
|
4
|
3
|
|
Randomization to Month 36
No Longer Met Study Criteria
|
0
|
0
|
2
|
|
Randomization to Month 36
Lack of Efficacy
|
19
|
15
|
17
|
|
Randomization to Month 36
Poor or Non-Compliance
|
0
|
0
|
1
|
|
Randomization to Month 36
Adverse Event
|
34
|
35
|
44
|
|
Randomization to Month 36
Withdrawal by Subject
|
3
|
4
|
5
|
|
Randomization to Month 36
Other
|
9
|
3
|
12
|
|
Long-Term Extension to Month 84
Death
|
8
|
13
|
7
|
|
Long-Term Extension to Month 84
No Longer Met Study Criteria
|
1
|
0
|
1
|
|
Long-Term Extension to Month 84
Lack of Efficacy
|
1
|
0
|
1
|
|
Long-Term Extension to Month 84
Poor or Non-Compliance
|
1
|
1
|
3
|
|
Long-Term Extension to Month 84
Adverse Event
|
15
|
14
|
7
|
|
Long-Term Extension to Month 84
Withdrawal by Subject
|
2
|
1
|
6
|
|
Long-Term Extension to Month 84
Lost to Follow-up
|
0
|
0
|
2
|
|
Long-Term Extension to Month 84
Administrative Reason by Sponsor
|
0
|
0
|
1
|
|
Long-Term Extension to Month 84
Other
|
2
|
0
|
2
|
Baseline Characteristics
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Baseline characteristics by cohort
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Age, Customized
18 to 45 years
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
34 participants
n=5 Participants
|
101 participants
n=4 Participants
|
|
Age, Customized
46 to 65 years
|
100 participants
n=5 Participants
|
97 participants
n=7 Participants
|
108 participants
n=5 Participants
|
305 participants
n=4 Participants
|
|
Age, Customized
more than 65 years
|
52 participants
n=5 Participants
|
43 participants
n=7 Participants
|
42 participants
n=5 Participants
|
137 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
364 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 12 post-transplantPopulation: All randomized and transplanted participants
Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant
|
85.9 percentage of participants
Interval 80.8 to 90.9
|
88.0 percentage of participants
Interval 83.2 to 92.8
|
84.8 percentage of participants
Interval 79.6 to 90.0
|
PRIMARY outcome
Timeframe: From Month 3 to Month 12Population: All randomized and transplanted participants
GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12
Measured GFR <60 mL/min/1.73 m^2 (Month 12)
|
55.7 percentage of participants
Interval 48.3 to 63.0
|
62.1 percentage of participants
Interval 54.8 to 69.4
|
67.4 percentage of participants
Interval 60.5 to 74.3
|
|
Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12
GFR ≥ 10 mL/min/1.73 m^2 (Month 3 to Month 12)
|
17.6 percentage of participants
Interval 12.0 to 23.2
|
27.2 percentage of participants
Interval 20.5 to 33.9
|
24.7 percentage of participants
Interval 18.4 to 31.1
|
SECONDARY outcome
Timeframe: At Month 12 and Month 24Population: All randomized and transplanted participants
GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, 'n' signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Measured Glomerular Filtration Rate (GFR) by Month 12 and 24
Month 12 (n = 154,151,154)
|
52.1 mL/min/1.73 m^2
Standard Deviation 21.9
|
49.5 mL/min/1.73 m^2
Standard Deviation 25.4
|
45.2 mL/min/1.73 m^2
Standard Deviation 21.1
|
|
Measured Glomerular Filtration Rate (GFR) by Month 12 and 24
Month 24 (n = 136,139,136)
|
51.5 mL/min/1.73 m^2
Standard Deviation 22.9
|
49.7 mL/min/1.73 m^2
Standard Deviation 23.67
|
45.0 mL/min/1.73 m^2
Standard Deviation 27.18
|
SECONDARY outcome
Timeframe: At Month 12Population: All randomized and transplanted participants
Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m\^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12
|
44.8 percentage of participants
Interval 37.6 to 52.0
|
46.0 percentage of participants
Interval 38.6 to 53.4
|
51.6 percentage of participants
Interval 44.4 to 58.9
|
SECONDARY outcome
Timeframe: Month 24 and Month 36 post-transplantPopulation: All randomized and transplanted participants
Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant
Month 24
|
82.6 percentage of participants
Interval 77.1 to 88.1
|
84.0 percentage of participants
Interval 78.6 to 89.4
|
82.6 percentage of participants
Interval 77.1 to 88.1
|
|
Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant
Month 36
|
80.4 percentage of participants
Interval 74.7 to 86.2
|
82.3 percentage of participants
Interval 76.6 to 87.9
|
79.9 percentage of participants
Interval 74.1 to 85.7
|
SECONDARY outcome
Timeframe: Months 6, 12, 24, 36 and 84Population: All randomized and transplanted participants
GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
Month 6 (n = 161,152,153)
|
43.6 participants
Standard Deviation 21.67
|
43.4 participants
Standard Deviation 18.57
|
35.5 participants
Standard Deviation 20.51
|
|
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
Month 12 (n = 159,154,154)
|
44.4 participants
Standard Deviation 22.78
|
44.8 participants
Standard Deviation 21.57
|
36.5 participants
Standard Deviation 21.08
|
|
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
Month 24 (n = 152,158,154)
|
44.4 participants
Standard Deviation 26.72
|
42.8 participants
Standard Deviation 24.07
|
34.9 participants
Standard Deviation 21.59
|
|
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
Month 36 (n = 152,154,143)
|
42.7 participants
Standard Deviation 27.59
|
42.2 participants
Standard Deviation 25.2
|
31.5 participants
Standard Deviation 22.13
|
|
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
Month 84 (n = 69,79,51)
|
57.6 participants
Standard Deviation 18.58
|
59.1 participants
Standard Deviation 18.85
|
44.6 participants
Standard Deviation 17.37
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36 and 84Population: All randomized and transplanted participants
GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Change in Calculated GFR at Months 12, 24, 36 and 84
Month 12 (n = 159,154,154)
|
-0.7 mL/min/1.73 m^2
Standard Deviation 17.96
|
-0.6 mL/min/1.73 m^2
Standard Deviation 15.39
|
-1.1 mL/min/1.73 m^2
Standard Deviation 12.48
|
|
Change in Calculated GFR at Months 12, 24, 36 and 84
Month 24 (n = 146,154,149)
|
-1.4 mL/min/1.73 m^2
Standard Deviation 17.68
|
-1.6 mL/min/1.73 m^2
Standard Deviation 18.7
|
-3.6 mL/min/1.73 m^2
Standard Deviation 15.37
|
|
Change in Calculated GFR at Months 12, 24, 36 and 84
Month 36 (n = 146,150,139)
|
-2.9 mL/min/1.73 m^2
Standard Deviation 23.7
|
-2.1 mL/min/1.73 m^2
Standard Deviation 20.92
|
-6.1 mL/min/1.73 m^2
Standard Deviation 17.39
|
|
Change in Calculated GFR at Months 12, 24, 36 and 84
Month 84 (n = 67,76,49)
|
7.5 mL/min/1.73 m^2
Standard Deviation 17.48
|
10.4 mL/min/1.73 m^2
Standard Deviation 17.54
|
-4.0 mL/min/1.73 m^2
Standard Deviation 17.17
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24 and 36Population: All randomized and transplanted participants
Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
1-2 Medications at Month 12 (n=184,175,184)
|
82 participants
|
79 participants
|
76 participants
|
|
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
≥ 3 Medications at Month 12 (n=184,175,184)
|
76 participants
|
66 participants
|
93 participants
|
|
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
1-2 Medications at Month 24 (n=177,170,179)
|
80 participants
|
79 participants
|
71 participants
|
|
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
≥ 3 Medications at Month 24 (n=177,170,179)
|
78 participants
|
65 participants
|
89 participants
|
|
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
1-2 Medications at Month 36 (n=151,145,143)
|
65 participants
|
67 participants
|
51 participants
|
|
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
≥ 3 Medications at Month 36 (n=151,145,143)
|
70 participants
|
60 participants
|
79 participants
|
SECONDARY outcome
Timeframe: Months 12, 24 and 36Population: All randomized and transplanted participants
Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36
Month 12 (n = 184,175,184)
|
87 percentage of participants
Interval 82.09 to 91.82
|
83.4 percentage of participants
Interval 77.92 to 88.94
|
87.0 percentage of participants
Interval 82.09 to 91.82
|
|
Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36
Month 24 (n = 177,170,179)
|
89.3 percentage of participants
Interval 84.71 to 93.83
|
84.7 percentage of participants
Interval 9.3 to 90.12
|
89.4 percentage of participants
Interval 84.87 to 93.9
|
|
Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36
Month 36 (n = 151,145,143)
|
89.4 percentage of participants
Interval 84.49 to 94.31
|
87.6 percentage of participants
Interval 82.22 to 92.25
|
90.9 percentage of participants
Interval 86.2 to 95.62
|
SECONDARY outcome
Timeframe: Months 12, 24 and 36Population: All randomized and transplanted participants
NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.
12 Month
|
2.3 percentage of participants
Interval 0.2 to 5.4
|
5.1 percentage of participants
Interval 1.4 to 8.9
|
9.3 percentage of participants
Interval 4.1 to 14.6
|
|
Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.
24 Month
|
3.0 percentage of participants
Interval 0.8 to 7.6
|
7.4 percentage of participants
Interval 3.0 to 11.7
|
9.3 percentage of participants
Interval 4.1 to 14.6
|
|
Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.
36 Month
|
5.3 percentage of participants
Interval 1.5 to 9.1
|
9.6 percentage of participants
Interval 4.6 to 14.5
|
9.3 percentage of participants
Interval 4.1 to 14.6
|
SECONDARY outcome
Timeframe: Months 12, 24 and 36Population: All randomized and transplanted participants
Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Diastolic BP (Month 12) (n= 184,175,184)
|
77.8 mmHg
Standard Deviation 13.83
|
78.3 mmHg
Standard Deviation 10.62
|
81.8 mmHg
Standard Deviation 11.68
|
|
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Systolic BP (Month 12) (n= 184,175,184)
|
141.4 mmHg
Standard Deviation 21.29
|
140.9 mmHg
Standard Deviation 21.09
|
149.5 mmHg
Standard Deviation 19.81
|
|
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Diastolic BP (Month 24) (n= 120,129,120)
|
78.2 mmHg
Standard Deviation 13.28
|
77.0 mmHg
Standard Deviation 11.18
|
81.7 mmHg
Standard Deviation 11.47
|
|
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Systolic BP (Month 24) (n= 120,129,120)
|
138.82 mmHg
Standard Deviation 24.31
|
136.7 mmHg
Standard Deviation 20.96
|
146.8 mmHg
Standard Deviation 21.11
|
|
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Diastolic BP (Month 36) (n= 112,119,108)
|
75.4 mmHg
Standard Deviation 11.55
|
75.2 mmHg
Standard Deviation 10.85
|
77.2 mmHg
Standard Deviation 11.79
|
|
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Systolic BP (Month 36) (n= 112,119,108)
|
134.9 mmHg
Standard Deviation 19.54
|
134.7 mmHg
Standard Deviation 21.59
|
140.7 mmHg
Standard Deviation 21.19
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24 and 36Population: All randomized and transplanted participants
The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from \<-3 to \>14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Mean Framingham Risk Score From Baseline to Months 12, 24 and 36
Month 12
|
5.3 units on a scale
Standard Deviation 4.11
|
4.5 units on a scale
Standard Deviation 4.02
|
6.0 units on a scale
Standard Deviation 3.98
|
|
Mean Framingham Risk Score From Baseline to Months 12, 24 and 36
Month 24
|
5.0 units on a scale
Standard Deviation 4.25
|
4.6 units on a scale
Standard Deviation 4.23
|
6.2 units on a scale
Standard Deviation 4.07
|
|
Mean Framingham Risk Score From Baseline to Months 12, 24 and 36
Month 36
|
5.2 units on a scale
Standard Deviation 4.18
|
4.9 units on a scale
Standard Deviation 3.84
|
5.8 units on a scale
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: Months 12, 24 and 36Population: All randomized and transplanted participants
Dyslipidemia was defined as triglyceride ≥ 500 mg/dL \[5.65 mmol/L\], low density lipoprotein (LDL) ≥ 100 mg/dL \[2.59 mmol/L\], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL \[3.36 mmol/L\]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months
Month 12 (n=184.175,184)
|
43.5 percentage of participants
Interval 36.3 to 50.6
|
40.0 percentage of participants
Interval 32.7 to 47.3
|
46.2 percentage of participants
Interval 39.0 to 53.2
|
|
Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months
Month 24 (n=184,175,184)
|
47.8 percentage of participants
Interval 40.6 to 55.0
|
42.3 percentage of participants
Interval 35.0 to 49.6
|
51.1 percentage of participants
Interval 43.9 to 58.3
|
|
Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months
Month 36 (n=151,145,143)
|
52.3 percentage of participants
Interval 44.4 to 60.3
|
45.5 percentage of participants
Interval 37.4 to 53.6
|
60.8 percentage of participants
Interval 52.8 to 68.8
|
SECONDARY outcome
Timeframe: Months 12, 24 and 36Population: All randomized and transplanted participants
Dyslipidemia was defined as triglyceride ≥ 500 mg/dL \[5.65 mmol/L\], low density lipoprotein (LDL) ≥ 100 mg/dL \[2.59 mmol/L\], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL \[3.36 mmol/L\]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Non-HDL (Month 12) (n=184,175,184)
|
134.5 mg/dL
Standard Deviation 45.04
|
134.2 mg/dL
Standard Deviation 40.69
|
153.4 mg/dL
Standard Deviation 46.99
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
TC (Month 12) (n =184,175,184)
|
183.7 mg/dL
Standard Deviation 47.72
|
184.1 mg/dL
Standard Deviation 45.51
|
201.3 mg/dL
Standard Deviation 49.49
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Triglyceride (Month 12) (n=184,175,184)
|
171.9 mg/dL
Standard Deviation 129.76
|
153.2 mg/dL
Standard Deviation 69.92
|
213.8 mg/dL
Standard Deviation 113.12
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
HDL (Month 12) (n=184,175,184)
|
49.2 mg/dL
Standard Deviation 13.73
|
49.8 mg/dL
Standard Deviation 15.85
|
47.9 mg/dL
Standard Deviation 14.76
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
LDL (Month 12) (n=184,175,184)
|
104.0 mg/dL
Standard Deviation 39.33
|
102.4 mg/dL
Standard Deviation 36.63
|
107.8 mg/dL
Standard Deviation 40.08
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Non--HDL (Month 24) (n=119,128,111)
|
126.1 mg/dL
Standard Deviation 45.45
|
129.8 mg/dL
Standard Deviation 37.89
|
148.7 mg/dL
Standard Deviation 60.46
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
TC (Month 24) (n=119,128,111)
|
175.6 mg/dL
Standard Deviation 47.99
|
178.0 mg/dL
Standard Deviation 41.9
|
195.7 mg/dL
Standard Deviation 61.46
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Triglyceride (Month 24) (n=98,104,93)
|
152.0 mg/dL
Standard Deviation 108.97
|
147.0 mg/dL
Standard Deviation 69.45
|
208.2 mg/dL
Standard Deviation 135.19
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
HDL (Month 24) (n=119,128,111)
|
49.5 mg/dL
Standard Deviation 16.27
|
48.2 mg/dL
Standard Deviation 14.41
|
47.0 mg/dL
Standard Deviation 17.77
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
LDL (Month 24) (n=97,104,93)
|
96.9 mg/dL
Standard Deviation 33.46
|
101.4 mg/dL
Standard Deviation 36.64
|
108.6 mg/dL
Standard Deviation 40.8
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Non-HDL (Month 36) (n=111,117,97)
|
132.6 mg/dL
Standard Deviation 41.86
|
132.2 mg/dL
Standard Deviation 46.81
|
139.1 mg/dL
Standard Deviation 49.68
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
TC (Month 36) (n=111,117,98)
|
181.0 mg/dL
Standard Deviation 43.84
|
181.9 mg/dL
Standard Deviation 49.16
|
196.7 mg/dL
Standard Deviation 127.35
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Triglyceride (Month 36) (n=80,88,78)
|
160.7 mg/dL
Standard Deviation 98.56
|
154.3 mg/dL
Standard Deviation 76.58
|
181.3 mg/dL
Standard Deviation 108.32
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
HDL (Month 36) (n=111,117,97)
|
48.9 mg/dL
Standard Deviation 14.82
|
49.6 mg/dL
Standard Deviation 16.24
|
47.0 mg/dL
Standard Deviation 14.28
|
|
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
LDL (Month 36) (n=79,88,77)
|
103.1 mg/dL
Standard Deviation 32.59
|
106.0 mg/dL
Standard Deviation 37.29
|
102.3 mg/dL
Standard Deviation 47.4
|
SECONDARY outcome
Timeframe: Months 6, 12, 24, 36 and 84Population: All randomized and transplanted participants
Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
Month 6
|
17.4 percentage of participants
Interval 11.9 to 22.9
|
16.6 percentage of participants
Interval 11.1 to 22.1
|
13.6 percentage of participants
Interval 8.6 to 18.5
|
|
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
Month 12
|
17.4 percentage of participants
Interval 11.9 to 22.9
|
17.7 percentage of participants
Interval 12.1 to 23.4
|
14.1 percentage of participants
Interval 9.1 to 19.2
|
|
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
Month 24
|
17.4 percentage of participants
Interval 11.9 to 22.9
|
18.3 percentage of participants
Interval 12.6 to 24.0
|
15.2 percentage of participants
Interval 10.0 to 20.4
|
|
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
Month 36
|
17.9 percentage of participants
Interval 12.4 to 23.5
|
18.9 percentage of participants
Interval 13.1 to 24.7
|
15.8 percentage of participants
Interval 10.5 to 21.0
|
|
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
Month 84
|
19.0 percentage of participants
Interval 13.4 to 24.7
|
19.4 percentage of participants
Interval 13.6 to 25.3
|
15.8 percentage of participants
Interval 10.5 to 21.1
|
SECONDARY outcome
Timeframe: Months 6, 12, 24 and 36Population: All randomized and transplanted participants
Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte -depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte -depletion therapy.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Only corticosteroid treated (Month 6)
|
14 participants
|
16 participants
|
9 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Corticosteroid resistant (Month 6)
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Lymphocyte-depleting treated (Month 6)
|
13 participants
|
5 participants
|
4 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Only corticosteroid treated (Month 12)
|
14 participants
|
16 participants
|
10 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Corticosteroid resistant (Month 12)
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Lymphocyte-depleting treated (Month 12)
|
13 participants
|
5 participants
|
4 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Only corticosteroid treated (Month 24)
|
13 participants
|
19 participants
|
11 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Corticosteroid resistant (Month 24)
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Lymphocyte-depleting treated (Month 24)
|
14 participants
|
7 participants
|
4 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Only corticosteroid treated (Month 36)
|
13 participants
|
19 participants
|
11 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Corticosteroid resistant (Month 36)
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Lymphocyte-depleting treated (Month 36)
|
14 participants
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Months 6, 12, 24, 36 and 84Population: All randomized and transplanted participants
Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IA) (Month 6)
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IB) (Month 6)
|
6 participants
|
2 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIA) (Month 6)
|
11 participants
|
15 participants
|
16 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IB) (Month 6)
|
15 participants
|
8 participants
|
5 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Severe acute (III) (Month 6)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IA) (Month 12)
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IB) (Month 12)
|
6 participants
|
2 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIA) (Month 12)
|
11 participants
|
17 participants
|
17 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IB) (Month 12)
|
15 participants
|
8 participants
|
5 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Severe acute (III) (Month 12)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IA) (Month 24)
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IB) (Month 24)
|
6 participants
|
2 participants
|
3 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIA) (Month 24)
|
10 participants
|
17 participants
|
18 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IB) (Month 24)
|
16 participants
|
9 participants
|
5 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Severe acute (III) (Month 24)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IA) (Month 36)
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IB) (Month 36)
|
6 participants
|
2 participants
|
4 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIA) (Month 36)
|
10 participants
|
18 participants
|
18 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIB) (Month 36)
|
16 participants
|
9 participants
|
5 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Severe acute (III) (Month 36)
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IA) (Month 84)
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Mild acute (IB) (Month 84)
|
6 participants
|
6 participants
|
4 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIA) (Month 84)
|
12 participants
|
18 participants
|
18 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Moderate acute (IIB) (Month 84)
|
16 participants
|
9 participants
|
5 participants
|
|
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Severe acute (III) (Month 84)
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24 and 36Population: Randomized and transplanted participants
The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Physical functioning (Month 12)
|
2.1 units on SF-36 scale
Standard Error 0.849
|
3.6 units on SF-36 scale
Standard Error 0.820
|
1.9 units on SF-36 scale
Standard Error 0.814
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Role-physical (Month 12)
|
5.2 units on SF-36 scale
Standard Error 0.912
|
6.2 units on SF-36 scale
Standard Error 0.883
|
4.7 units on SF-36 scale
Standard Error 0.877
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Bodily pain (Month 12)
|
2.9 units on SF-36 scale
Standard Error 0.925
|
0.9 units on SF-36 scale
Standard Error 0.887
|
-0.7 units on SF-36 scale
Standard Error 0.890
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
General health (Month 12)
|
2.9 units on SF-36 scale
Standard Error 0.747
|
2.4 units on SF-36 scale
Standard Error 0.722
|
2.1 units on SF-36 scale
Standard Error 0.719
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Vitality (Month 12)
|
4.1 units on SF-36 scale
Standard Error 0.845
|
3.6 units on SF-36 scale
Standard Error 0.814
|
2.9 units on SF-36 scale
Standard Error 0.808
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Social functioning (Month 12)
|
4.2 units on SF-36 scale
Standard Error 0.863
|
3.5 units on SF-36 scale
Standard Error 0.830
|
2.1 units on SF-36 scale
Standard Error 0.827
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Role-emotional (Month 12)
|
2.0 units on SF-36 scale
Standard Error 1.049
|
2.4 units on SF-36 scale
Standard Error 1.019
|
3.5 units on SF-36 scale
Standard Error 1.026
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Mental health (Month 12)
|
2.7 units on SF-36 scale
Standard Error 0.909
|
1.7 units on SF-36 scale
Standard Error 0.875
|
2.4 units on SF-36 scale
Standard Error 0.869
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Physical functioning (Month 24)
|
1.5 units on SF-36 scale
Standard Error 0.826
|
3.5 units on SF-36 scale
Standard Error 0.810
|
0.7 units on SF-36 scale
Standard Error 0.804
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Role-physical (Month 24)
|
5.3 units on SF-36 scale
Standard Error 0.845
|
6.1 units on SF-36 scale
Standard Error 0.830
|
4.3 units on SF-36 scale
Standard Error 0.827
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Bodily pain (Month 24)
|
2.0 units on SF-36 scale
Standard Error 0.915
|
0.0 units on SF-36 scale
Standard Error 0.891
|
-1.9 units on SF-36 scale
Standard Error 0.891
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
General health (Month 24)
|
2.6 units on SF-36 scale
Standard Error 0.749
|
2.0 units on SF-36 scale
Standard Error 0.737
|
0.6 units on SF-36 scale
Standard Error 0.732
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Vitality (Month 24)
|
3.9 units on SF-36 scale
Standard Error 0.813
|
3.1 units on SF-36 scale
Standard Error 0.801
|
1.4 units on SF-36 scale
Standard Error 0.793
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Social functioning (Month 24)
|
3.2 units on SF-36 scale
Standard Error 0.824
|
5.0 units on SF-36 scale
Standard Error 0.807
|
2.1 units on SF-36 scale
Standard Error 0.805
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Role-emotional (Month 24)
|
2.5 units on SF-36 scale
Standard Error 0.990
|
3.0 units on SF-36 scale
Standard Error 0.972
|
2.9 units on SF-36 scale
Standard Error 0.979
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Mental health (Month 24)
|
3.0 units on SF-36 scale
Standard Error 0.883
|
1.9 units on SF-36 scale
Standard Error 0.869
|
1.4 units on SF-36 scale
Standard Error 0.861
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Physical functioning (Month 36)
|
1.3 units on SF-36 scale
Standard Error 0.893
|
3.0 units on SF-36 scale
Standard Error 0.872
|
0.7 units on SF-36 scale
Standard Error 0.866
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Role-physical (Month 36)
|
5.7 units on SF-36 scale
Standard Error 0.868
|
5.8 units on SF-36 scale
Standard Error 0.856
|
4.1 units on SF-36 scale
Standard Error 0.844
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Bodily pain (Month 36)
|
1.6 units on SF-36 scale
Standard Error 0.899
|
0.3 units on SF-36 scale
Standard Error 0.875
|
-2.2 units on SF-36 scale
Standard Error 0.869
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
General health (Month 36)
|
2.1 units on SF-36 scale
Standard Error 0.785
|
0.9 units on SF-36 scale
Standard Error 0.773
|
-0.5 units on SF-36 scale
Standard Error 0.768
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Vitality (Month 36)
|
4.1 units on SF-36 scale
Standard Error 0.837
|
2.5 units on SF-36 scale
Standard Error 0.823
|
1.4 units on SF-36 scale
Standard Error 0.813
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Social functioning (Month 36)
|
2.9 units on SF-36 scale
Standard Error 0.847
|
4.6 units on SF-36 scale
Standard Error 0.830
|
1.4 units on SF-36 scale
Standard Error 0.825
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Role-emotional (Month 36)
|
2.2 units on SF-36 scale
Standard Error 1.003
|
2.4 units on SF-36 scale
Standard Error 0.992
|
2.5 units on SF-36 scale
Standard Error 0.988
|
|
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Mental health (Month 36)
|
3.6 units on SF-36 scale
Standard Error 0.855
|
0.7 units on SF-36 scale
Standard Error 0.841
|
0.9 units on SF-36 scale
Standard Error 0.830
|
SECONDARY outcome
Timeframe: Day 1 to Month 36Population: All randomized and transplanted participants
Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months
Body Weight
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months
Heart Rate
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months
Body Temperature
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Month 36Population: All randomized and transplanted participants.
Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Hemoglobin (Low) (n=177,172,181)
|
25 participants
|
24 participants
|
16 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Platelet Count (Low) (n=177,172,181)
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Leukocytes (Low) (n=177,172,181)
|
10 participants
|
5 participants
|
8 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
ALP (High) (n=177,172,182)
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
ALT (High) (n=177,172,181)
|
4 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
AST (High) (n=177,172,181)
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Bilirubin, Total (High) (n=177,172,182)
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Creatinine (High) (n=177,172,182)
|
125 participants
|
117 participants
|
128 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Calcium, Total (Low) (n=177,172,182)
|
19 participants
|
14 participants
|
10 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Calcium, Total (High) (n=177,172,182)
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Bicarbonate (Low) (n=176,171,181)
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Bicarbonate (High) (n=176,171,181)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Potassium, Serum (Low)(n=177,172,181)
|
6 participants
|
3 participants
|
9 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Potassium, Serum (High)(n=177,172,181)
|
8 participants
|
6 participants
|
11 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Magnesium, Serum (Low)(n=177,172,181)
|
6 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Magnesium, Serum (High)(n=177,172,181)
|
6 participants
|
4 participants
|
9 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Sodium, Serum (Low)(n=177,172,181)
|
18 participants
|
16 participants
|
23 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Sodium, Serum (High)(n=177,172,181)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Phosphorus (Low) (n=177,172,182)
|
66 participants
|
58 participants
|
44 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Albumin (Low) (n=177,172,182)
|
2 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Uric Acid (High) (n=177,172,182)
|
31 participants
|
34 participants
|
60 participants
|
|
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Protein, Urine (High) (n=173,168,177)
|
44 participants
|
37 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Day 1 to Month 36Population: All randomized and transplanted participants
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
AEs
|
182 participants
|
174 participants
|
184 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
SAEs
|
149 participants
|
139 participants
|
146 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
AEs leading to Discontinuation
|
34 participants
|
36 participants
|
44 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
SAEs leading to Discontinuation
|
31 participants
|
31 participants
|
28 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
Related AEs
|
115 participants
|
106 participants
|
141 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
Related SAEs
|
60 participants
|
51 participants
|
58 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
Deaths
|
22 participants
|
15 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Day 1 to Month 84Population: All randomized and transplanted participants who completed 36 months of treatment and continued into long-term extension phase
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=104 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=113 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=87 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
AEs
|
104 participants
|
113 participants
|
87 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
SAEs
|
94 participants
|
104 participants
|
73 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
AEs leading to Discontinuation
|
14 participants
|
14 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
SAEs leading to Discontinuation
|
94 participants
|
104 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
Deaths
|
14 participants
|
21 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Randomization to date of death, up to 84 monthsPopulation: All randomized and transplanted participants
Participant and graft survival at 84 months was summarized within each treatment group.
Outcome measures
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 Participants
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin A (CsA)
n=184 Participants
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Percentage of Participants With Graft Loss or Death to Month 84
Graft Loss or Death
|
29.3 percentage of participants
|
30.9 percentage of participants
|
28.3 percentage of participants
|
|
Percentage of Participants With Graft Loss or Death to Month 84
Graft Loss
|
11.4 percentage of participants
|
13.1 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants With Graft Loss or Death to Month 84
Death
|
20.1 percentage of participants
|
21.1 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants With Graft Loss or Death to Month 84
Death with Functioning Graft
|
17.9 percentage of participants
|
17.7 percentage of participants
|
12.5 percentage of participants
|
Adverse Events
Belatacept More Intensive (MI) Regimen
Serious events: 162 serious events
Other events: 177 other events
Deaths: 0 deaths
Belatacept Less Intensive (LI) Regimen
Serious events: 157 serious events
Other events: 171 other events
Deaths: 0 deaths
Cyclosporin (CsA)
Serious events: 152 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 participants at risk
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 participants at risk
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin (CsA)
n=184 participants at risk
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.1%
2/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Abscess limb
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Aspergillus infection
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
4.9%
9/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
2/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardiac failure congestive
|
5.4%
10/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Chronic allograft nephropathy
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
General disorders
Cyst
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus gastritis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus infection
|
9.8%
18/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
General disorders
Death
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Endocarditis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Erysipelas
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastritis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Hepatic mass
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Herpes zoster
|
4.3%
8/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Hypertensive crisis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
3/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Ileus
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Lymphangitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Non-cardiac chest pain
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Oesophagitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Oral fungal infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Peritoneal disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Prostatism
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal failure
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
4.3%
8/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Ureteric stenosis
|
2.2%
4/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urinary fistula
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Varicella
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Vesical fistula
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Viral infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal distension
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Antibody test positive
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Appendicitis
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Arterial stenosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
BK virus infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Bronchitis
|
1.6%
3/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardiogenic shock
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cerebral aspergillosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholangitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Chorioretinitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
7/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Diverticulum
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Dyspepsia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Hepatic cyst infection
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Leishmaniasis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Lower respiratory tract infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Malaise
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Mitral valve stenosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
General disorders
Oedema
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Oesophageal candidiasis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
1.1%
2/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Phlebitis
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Proteinuria
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Pseudomonal sepsis
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Infections and infestations
Renal cyst infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Sinusitis
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
4.9%
9/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Infections and infestations
Tuberculosis of eye
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Eye disorders
Uveitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Volvulus
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Weight increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.54%
1/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
11/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.6%
3/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Blood creatine increased
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
2.2%
4/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Device malfunction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
18/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Duodenitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Escherichia sepsis
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Fatigue
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Fungal infection
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Graft loss
|
2.2%
4/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Vascular disorders
Haematoma
|
1.1%
2/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Vascular disorders
Haemorrhagic infarction
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Incarcerated hernia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Influenza
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Kidney rupture
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Lung infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Eye disorders
Macular oedema
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Neurotoxicity
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Overdose
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Perinephric effusion
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Peripheral artery stenosis
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal infarct
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal vein thrombosis
|
3.3%
6/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
3/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Septic shock
|
1.1%
2/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.6%
3/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Strongyloidiasis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
3/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Upper respiratory tract infection
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.54%
1/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Weight decreased
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Angiopathy
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Aortic valve stenosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Bladder prolapse
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cerebral fungal infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Deep vein thrombosis
|
3.8%
7/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Nervous system disorders
Dementia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Dysentery
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Dysuria
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Emphysematous cystitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Enterococcus test positive
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Epilepsy
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Haemorrhage
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Impaired healing
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
General disorders
Influenza like illness
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Liver function test abnormal
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Lobar pneumonia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Mycoplasma infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Myocardial infarction
|
3.8%
7/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Perirectal abscess
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.6%
3/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.6%
3/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal tubular atrophy
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Eye disorders
Retinal detachment
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Sepsis
|
4.3%
8/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
8.2%
15/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Sinusitis bacterial
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
General disorders
Sudden death
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Psychiatric disorders
Suicide attempt
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Wound infection
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Abscess rupture
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Aortic valve disease
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Bacterial pyelonephritis
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Cardiac death
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Cerebrovascular accident
|
3.3%
6/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Clostridium difficile colitis
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Convulsion
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Infections and infestations
Cystitis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus enteritis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Diabetic gangrene
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Drug intolerance
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.6%
3/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Haematuria
|
2.2%
4/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Hernia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Human polyomavirus infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Klebsiella infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Microalbuminuria
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Multi-organ failure
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Myocardial ischaemia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Osteomyelitis
|
2.2%
4/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia bacterial
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Polyomavirus test positive
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Pyelonephritis acute
|
2.2%
4/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
3.8%
7/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal artery dissection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Tachyarrhythmia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Uterine malposition
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Venous thrombosis limb
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Investigations
White blood cells urine positive
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Acute coronary syndrome
|
0.54%
1/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Psychiatric disorders
Acute psychosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Anal abscess
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Asthenia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Blood creatinine increased
|
7.6%
14/184 • Randomization to Month 84
|
6.3%
11/175 • Randomization to Month 84
|
9.2%
17/184 • Randomization to Month 84
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Blood pressure increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
C-reactive protein increased
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardiac failure
|
1.6%
3/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Cerebral ischaemia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Chest pain
|
2.7%
5/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Psychiatric disorders
Confusional state
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
2/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus syndrome
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Diabetic bullosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Gastroenteritis
|
4.3%
8/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Eye disorders
Glaucoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Hepatitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Hypotension
|
2.2%
4/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Infection
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Joint tuberculosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Infections and infestations
Kidney infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Localised infection
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Meningitis cryptococcal
|
1.1%
2/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
3/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Oral candidiasis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Peripheral swelling
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia
|
8.2%
15/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal failure acute
|
3.8%
7/184 • Randomization to Month 84
|
6.9%
12/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Staphylococcal sepsis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Tooth abscess
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Transplant abscess
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.54%
1/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Infections and infestations
Urosepsis
|
3.3%
6/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Ventricular tachycardia
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Arrhythmia
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Bradycardia
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Eye disorders
Cataract
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Colitis
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
1.6%
3/184 • Randomization to Month 84
|
4.6%
8/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Infections and infestations
Cystitis bacterial
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus gastrointestinal infection
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Disseminated cytomegaloviral infection
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Diverticulitis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Nervous system disorders
Encephalitis toxic
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Encephalomyelitis
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Epididymitis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epiglottic carcinoma
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
Escherichia test positive
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Helicobacter gastritis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
2/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Hypertension
|
1.1%
2/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Incision site infection
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Infected cyst
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
International normalised ratio increased
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
8/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Vascular disorders
Lymphocele
|
1.1%
2/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Nephropathy
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
General disorders
Oedema peripheral
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Partial seizures
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Postrenal failure
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Prostatitis
|
0.54%
1/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Pyelonephritis
|
6.5%
12/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
7.6%
14/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
2/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Renal transplant failure
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Nervous system disorders
Sciatica
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Thrombosis
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Tuberculous laryngitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urinary incontinence
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Infections and infestations
Urinary tract infection
|
13.6%
25/184 • Randomization to Month 84
|
16.0%
28/175 • Randomization to Month 84
|
14.1%
26/184 • Randomization to Month 84
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Abscess
|
1.6%
3/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
2/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Adverse drug reaction
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Cardiac disorders
Angina pectoris
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Atrial fibrillation
|
4.9%
9/184 • Randomization to Month 84
|
6.3%
11/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Cardiac disorders
Atrial flutter
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Infections and infestations
Bacteraemia
|
1.6%
3/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Infections and infestations
Bacterial prostatitis
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Brain mass
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cellulitis
|
2.7%
5/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Cryptococcosis
|
0.54%
1/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Device related infection
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Nervous system disorders
Dizziness
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Extravasation
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Gangrene
|
2.2%
4/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Graft complication
|
1.6%
3/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.54%
1/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Necrotising fasciitis
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Oral disorder
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
2/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.6%
3/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Investigations
Platelet count decreased
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Post transplant distal limb syndrome
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Infections and infestations
Postoperative wound infection
|
1.6%
3/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Prerenal failure
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
2/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Infections and infestations
Psoas abscess
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
General disorders
Pyrexia
|
9.2%
17/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.1%
2/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
3.8%
7/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal haemorrhage
|
1.1%
2/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal tubular necrosis
|
2.2%
4/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Vascular disorders
Shock
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Ureteric fistula
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.54%
1/184 • Randomization to Month 84
|
|
Eye disorders
Visual acuity reduced
|
0.54%
1/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Eye disorders
Visual impairment
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
0.00%
0/184 • Randomization to Month 84
|
|
Investigations
White blood cell count decreased
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
1.1%
2/184 • Randomization to Month 84
|
Other adverse events
| Measure |
Belatacept More Intensive (MI) Regimen
n=184 participants at risk
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
|
Belatacept Less Intensive (LI) Regimen
n=175 participants at risk
Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
|
Cyclosporin (CsA)
n=184 participants at risk
Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
|
|---|---|---|---|
|
General disorders
Chills
|
4.9%
9/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Chronic allograft nephropathy
|
7.6%
14/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
12.0%
22/184 • Randomization to Month 84
|
|
Infections and infestations
Conjunctivitis
|
8.2%
15/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
3.8%
7/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Constipation
|
33.2%
61/184 • Randomization to Month 84
|
36.0%
63/175 • Randomization to Month 84
|
42.9%
79/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
8/184 • Randomization to Month 84
|
6.3%
11/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Infections and infestations
Cytomegalovirus infection
|
12.0%
22/184 • Randomization to Month 84
|
10.3%
18/175 • Randomization to Month 84
|
9.2%
17/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
18.5%
34/184 • Randomization to Month 84
|
16.6%
29/175 • Randomization to Month 84
|
22.3%
41/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
8/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Infections and infestations
Herpes zoster
|
11.4%
21/184 • Randomization to Month 84
|
9.7%
17/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.4%
21/184 • Randomization to Month 84
|
11.4%
20/175 • Randomization to Month 84
|
12.5%
23/184 • Randomization to Month 84
|
|
Endocrine disorders
Hyperparathyroidism
|
3.8%
7/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.4%
10/184 • Randomization to Month 84
|
6.9%
12/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.2%
15/184 • Randomization to Month 84
|
6.9%
12/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.3%
8/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
13/184 • Randomization to Month 84
|
8.6%
15/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
13/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
10.3%
19/184 • Randomization to Month 84
|
|
Infections and infestations
Bronchitis
|
20.1%
37/184 • Randomization to Month 84
|
20.6%
36/175 • Randomization to Month 84
|
13.6%
25/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
13/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
22/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
10.9%
20/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.1%
13/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Infections and infestations
Escherichia urinary tract infection
|
4.9%
9/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.7%
16/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.7%
16/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
16.8%
31/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.7%
5/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
General disorders
Oedema
|
14.1%
26/184 • Randomization to Month 84
|
13.1%
23/175 • Randomization to Month 84
|
16.3%
30/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Proteinuria
|
21.7%
40/184 • Randomization to Month 84
|
20.6%
36/175 • Randomization to Month 84
|
15.8%
29/184 • Randomization to Month 84
|
|
Infections and infestations
Sinusitis
|
10.3%
19/184 • Randomization to Month 84
|
13.1%
23/175 • Randomization to Month 84
|
10.9%
20/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
35.3%
65/184 • Randomization to Month 84
|
36.6%
64/175 • Randomization to Month 84
|
46.2%
85/184 • Randomization to Month 84
|
|
Ear and labyrinth disorders
Vertigo
|
2.7%
5/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Investigations
Weight increased
|
8.2%
15/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.6%
3/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal pain
|
16.3%
30/184 • Randomization to Month 84
|
22.3%
39/175 • Randomization to Month 84
|
17.9%
33/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Anaemia
|
53.3%
98/184 • Randomization to Month 84
|
53.1%
93/175 • Randomization to Month 84
|
56.0%
103/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.4%
10/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
2.2%
4/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.8%
53/184 • Randomization to Month 84
|
32.0%
56/175 • Randomization to Month 84
|
22.3%
41/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Diarrhoea
|
56.0%
103/184 • Randomization to Month 84
|
53.7%
94/175 • Randomization to Month 84
|
40.2%
74/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.9%
33/184 • Randomization to Month 84
|
22.9%
40/175 • Randomization to Month 84
|
20.1%
37/184 • Randomization to Month 84
|
|
General disorders
Fatigue
|
14.1%
26/184 • Randomization to Month 84
|
12.6%
22/175 • Randomization to Month 84
|
10.3%
19/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/184 • Randomization to Month 84
|
0.00%
0/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Vascular disorders
Haematoma
|
8.7%
16/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
9.8%
18/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
4.3%
8/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.5%
47/184 • Randomization to Month 84
|
22.9%
40/175 • Randomization to Month 84
|
21.7%
40/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.2%
15/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Incision site pain
|
14.1%
26/184 • Randomization to Month 84
|
12.6%
22/175 • Randomization to Month 84
|
19.6%
36/184 • Randomization to Month 84
|
|
Infections and infestations
Influenza
|
9.2%
17/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
9.8%
18/184 • Randomization to Month 84
|
|
Infections and infestations
Nasopharyngitis
|
24.5%
45/184 • Randomization to Month 84
|
25.1%
44/175 • Randomization to Month 84
|
20.7%
38/184 • Randomization to Month 84
|
|
General disorders
Pain
|
7.1%
13/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
7.6%
14/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.54%
1/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Infections and infestations
Respiratory tract infection
|
3.3%
6/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
24/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Nervous system disorders
Tremor
|
9.2%
17/184 • Randomization to Month 84
|
12.0%
21/175 • Randomization to Month 84
|
16.8%
31/184 • Randomization to Month 84
|
|
Infections and infestations
Upper respiratory tract infection
|
19.0%
35/184 • Randomization to Month 84
|
16.6%
29/175 • Randomization to Month 84
|
12.5%
23/184 • Randomization to Month 84
|
|
Investigations
Weight decreased
|
9.2%
17/184 • Randomization to Month 84
|
12.0%
21/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.6%
14/184 • Randomization to Month 84
|
10.3%
18/175 • Randomization to Month 84
|
10.3%
19/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.2%
15/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Dysuria
|
13.6%
25/184 • Randomization to Month 84
|
13.1%
23/175 • Randomization to Month 84
|
8.7%
16/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.9%
9/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Nervous system disorders
Headache
|
20.1%
37/184 • Randomization to Month 84
|
23.4%
41/175 • Randomization to Month 84
|
25.5%
47/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Hydronephrosis
|
4.9%
9/184 • Randomization to Month 84
|
1.1%
2/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.54%
1/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
8.7%
16/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.4%
21/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
14.1%
26/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
8.2%
15/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
8.7%
16/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.2%
17/184 • Randomization to Month 84
|
9.7%
17/175 • Randomization to Month 84
|
10.3%
19/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
11/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
9.2%
17/184 • Randomization to Month 84
|
|
Infections and infestations
Oral herpes
|
7.1%
13/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Polycythaemia
|
2.2%
4/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
3.8%
7/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
16/184 • Randomization to Month 84
|
4.6%
8/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.4%
21/184 • Randomization to Month 84
|
14.3%
25/175 • Randomization to Month 84
|
14.7%
27/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
2.2%
4/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
33/184 • Randomization to Month 84
|
24.6%
43/175 • Randomization to Month 84
|
18.5%
34/184 • Randomization to Month 84
|
|
Infections and infestations
Fungal skin infection
|
4.3%
8/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Gout
|
1.6%
3/184 • Randomization to Month 84
|
6.3%
11/175 • Randomization to Month 84
|
3.8%
7/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Haematuria
|
22.3%
41/184 • Randomization to Month 84
|
22.3%
39/175 • Randomization to Month 84
|
19.6%
36/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
23.4%
43/184 • Randomization to Month 84
|
26.9%
47/175 • Randomization to Month 84
|
23.9%
44/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
19.0%
35/184 • Randomization to Month 84
|
21.1%
37/175 • Randomization to Month 84
|
12.0%
22/184 • Randomization to Month 84
|
|
Psychiatric disorders
Insomnia
|
20.1%
37/184 • Randomization to Month 84
|
17.7%
31/175 • Randomization to Month 84
|
21.2%
39/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Leukocyturia
|
7.1%
13/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
7.1%
13/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.0%
35/184 • Randomization to Month 84
|
19.4%
34/175 • Randomization to Month 84
|
22.8%
42/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.9%
9/184 • Randomization to Month 84
|
10.3%
18/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
8/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Cardiac disorders
Tachycardia
|
7.6%
14/184 • Randomization to Month 84
|
12.6%
22/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.54%
1/184 • Randomization to Month 84
|
0.57%
1/175 • Randomization to Month 84
|
9.8%
18/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Vomiting
|
20.1%
37/184 • Randomization to Month 84
|
29.1%
51/175 • Randomization to Month 84
|
23.9%
44/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.6%
3/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Psychiatric disorders
Anxiety
|
14.7%
27/184 • Randomization to Month 84
|
11.4%
20/175 • Randomization to Month 84
|
16.3%
30/184 • Randomization to Month 84
|
|
General disorders
Asthenia
|
12.5%
23/184 • Randomization to Month 84
|
9.7%
17/175 • Randomization to Month 84
|
12.5%
23/184 • Randomization to Month 84
|
|
Investigations
Blood creatinine increased
|
15.8%
29/184 • Randomization to Month 84
|
16.6%
29/175 • Randomization to Month 84
|
16.8%
31/184 • Randomization to Month 84
|
|
Investigations
Blood pressure increased
|
4.3%
8/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Investigations
C-reactive protein increased
|
6.5%
12/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
General disorders
Chest pain
|
12.0%
22/184 • Randomization to Month 84
|
13.7%
24/175 • Randomization to Month 84
|
13.0%
24/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.2%
15/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
9.2%
17/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
5/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Infections and infestations
Gastroenteritis
|
4.3%
8/184 • Randomization to Month 84
|
10.3%
18/175 • Randomization to Month 84
|
12.0%
22/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
13.0%
24/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
12.0%
22/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.1%
13/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
8.7%
16/184 • Randomization to Month 84
|
8.6%
15/175 • Randomization to Month 84
|
8.2%
15/184 • Randomization to Month 84
|
|
Vascular disorders
Hypotension
|
20.7%
38/184 • Randomization to Month 84
|
29.7%
52/175 • Randomization to Month 84
|
15.8%
29/184 • Randomization to Month 84
|
|
Cardiac disorders
Left ventricular hypertrophy
|
2.7%
5/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
12/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Infections and infestations
Onychomycosis
|
7.6%
14/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Infections and infestations
Oral candidiasis
|
7.6%
14/184 • Randomization to Month 84
|
5.7%
10/175 • Randomization to Month 84
|
7.1%
13/184 • Randomization to Month 84
|
|
General disorders
Peripheral swelling
|
5.4%
10/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Infections and infestations
Pneumonia
|
3.8%
7/184 • Randomization to Month 84
|
8.6%
15/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal failure acute
|
2.2%
4/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Urinary retention
|
2.7%
5/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Cardiac disorders
Bradycardia
|
5.4%
10/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Eye disorders
Cataract
|
10.9%
20/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
8.7%
16/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
5.4%
10/184 • Randomization to Month 84
|
11.4%
20/175 • Randomization to Month 84
|
9.2%
17/184 • Randomization to Month 84
|
|
Endocrine disorders
Cushingoid
|
3.3%
6/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
16/184 • Randomization to Month 84
|
4.6%
8/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.0%
11/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
19.0%
35/184 • Randomization to Month 84
|
16.6%
29/175 • Randomization to Month 84
|
20.1%
37/184 • Randomization to Month 84
|
|
Vascular disorders
Hypertension
|
34.2%
63/184 • Randomization to Month 84
|
36.0%
63/175 • Randomization to Month 84
|
43.5%
80/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
19.0%
35/184 • Randomization to Month 84
|
19.4%
34/175 • Randomization to Month 84
|
12.0%
22/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.7%
51/184 • Randomization to Month 84
|
22.9%
40/175 • Randomization to Month 84
|
26.1%
48/184 • Randomization to Month 84
|
|
Vascular disorders
Lymphocele
|
4.9%
9/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
8.2%
15/184 • Randomization to Month 84
|
|
General disorders
Oedema peripheral
|
50.0%
92/184 • Randomization to Month 84
|
46.3%
81/175 • Randomization to Month 84
|
52.2%
96/184 • Randomization to Month 84
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
16/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.4%
10/184 • Randomization to Month 84
|
4.0%
7/175 • Randomization to Month 84
|
3.3%
6/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal impairment
|
7.1%
13/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
10.3%
19/184 • Randomization to Month 84
|
|
Infections and infestations
Rhinitis
|
6.0%
11/184 • Randomization to Month 84
|
4.6%
8/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Nervous system disorders
Sciatica
|
3.8%
7/184 • Randomization to Month 84
|
6.3%
11/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
9.8%
18/184 • Randomization to Month 84
|
8.6%
15/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.0%
11/184 • Randomization to Month 84
|
3.4%
6/175 • Randomization to Month 84
|
6.0%
11/184 • Randomization to Month 84
|
|
Infections and infestations
Urinary tract infection
|
42.9%
79/184 • Randomization to Month 84
|
43.4%
76/175 • Randomization to Month 84
|
46.7%
86/184 • Randomization to Month 84
|
|
Metabolism and nutrition disorders
Acidosis
|
8.7%
16/184 • Randomization to Month 84
|
8.0%
14/175 • Randomization to Month 84
|
8.2%
15/184 • Randomization to Month 84
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.8%
7/184 • Randomization to Month 84
|
6.9%
12/175 • Randomization to Month 84
|
8.2%
15/184 • Randomization to Month 84
|
|
Cardiac disorders
Angina pectoris
|
2.7%
5/184 • Randomization to Month 84
|
4.6%
8/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Cardiac disorders
Atrial fibrillation
|
8.7%
16/184 • Randomization to Month 84
|
6.3%
11/175 • Randomization to Month 84
|
6.5%
12/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.3%
41/184 • Randomization to Month 84
|
25.1%
44/175 • Randomization to Month 84
|
21.2%
39/184 • Randomization to Month 84
|
|
Psychiatric disorders
Depression
|
4.3%
8/184 • Randomization to Month 84
|
9.1%
16/175 • Randomization to Month 84
|
9.8%
18/184 • Randomization to Month 84
|
|
Nervous system disorders
Dizziness
|
14.1%
26/184 • Randomization to Month 84
|
10.3%
18/175 • Randomization to Month 84
|
9.8%
18/184 • Randomization to Month 84
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.5%
12/184 • Randomization to Month 84
|
5.1%
9/175 • Randomization to Month 84
|
2.7%
5/184 • Randomization to Month 84
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.4%
10/184 • Randomization to Month 84
|
6.9%
12/175 • Randomization to Month 84
|
4.3%
8/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
4/184 • Randomization to Month 84
|
2.3%
4/175 • Randomization to Month 84
|
5.4%
10/184 • Randomization to Month 84
|
|
Gastrointestinal disorders
Nausea
|
29.3%
54/184 • Randomization to Month 84
|
28.0%
49/175 • Randomization to Month 84
|
28.3%
52/184 • Randomization to Month 84
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
5/184 • Randomization to Month 84
|
2.9%
5/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
|
Nervous system disorders
Paraesthesia
|
6.0%
11/184 • Randomization to Month 84
|
7.4%
13/175 • Randomization to Month 84
|
8.7%
16/184 • Randomization to Month 84
|
|
Injury, poisoning and procedural complications
Procedural pain
|
19.6%
36/184 • Randomization to Month 84
|
21.7%
38/175 • Randomization to Month 84
|
20.1%
37/184 • Randomization to Month 84
|
|
General disorders
Pyrexia
|
30.4%
56/184 • Randomization to Month 84
|
36.6%
64/175 • Randomization to Month 84
|
28.3%
52/184 • Randomization to Month 84
|
|
Renal and urinary disorders
Renal tubular necrosis
|
9.2%
17/184 • Randomization to Month 84
|
12.0%
21/175 • Randomization to Month 84
|
16.3%
30/184 • Randomization to Month 84
|
|
Infections and infestations
Tinea versicolour
|
1.1%
2/184 • Randomization to Month 84
|
1.7%
3/175 • Randomization to Month 84
|
4.9%
9/184 • Randomization to Month 84
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60