Trial Outcomes & Findings for Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients (NCT NCT00251004)
NCT ID: NCT00251004
Last Updated: 2011-05-10
Results Overview
The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
833 participants
Primary outcome timeframe
12 months
Results posted on
2011-05-10
Participant Flow
Participant milestones
| Measure |
Low-dose Everolimus Group
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
277
|
279
|
277
|
|
Overall Study
12 Month Analysis
|
241
|
249
|
253
|
|
Overall Study
24 Month Analysis
|
232
|
238
|
246
|
|
Overall Study
COMPLETED
|
232
|
238
|
246
|
|
Overall Study
NOT COMPLETED
|
45
|
41
|
31
|
Reasons for withdrawal
| Measure |
Low-dose Everolimus Group
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
16
|
14
|
|
Overall Study
Death
|
9
|
10
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Graft Loss
|
12
|
13
|
8
|
Baseline Characteristics
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Low-dose Everolimus Group
n=277 Participants
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=279 Participants
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=277 Participants
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
45.7 Years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
45.3 Years
STANDARD_DEVIATION 13.36 • n=7 Participants
|
47.2 Years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
46.1 Years
STANDARD_DEVIATION 12.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
557 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intention-to-treat (ITT) population
The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.
Outcome measures
| Measure |
Low-dose Everolimus Group
n=277 Participants
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=279 Participants
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=277 Participants
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis
Composite Endpoint (n)
|
75 Participants
|
60 Participants
|
70 Participants
|
|
Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis
--Death
|
8 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis
--Graft Loss
|
13 Participants
|
13 Participants
|
9 Participants
|
|
Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis
--Treated BPAR
|
48 Participants
|
38 Participants
|
50 Participants
|
|
Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis
--Lost to follow up
|
12 Participants
|
6 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intention-to-treat population
The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.
Outcome measures
| Measure |
Low-dose Everolimus Group
n=277 Participants
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=279 Participants
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=277 Participants
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints
|
27.1 Percentage of Participants
|
21.5 Percentage of Participants
|
25.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-treat (ITT) population.
Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant. A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316.
Outcome measures
| Measure |
Low-dose Everolimus Group
n=277 Participants
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=279 Participants
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=277 Participants
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation
|
11.6 Percentage of participants
|
9.7 Percentage of participants
|
9.4 Percentage of participants
|
SECONDARY outcome
Timeframe: at 12 monthsPopulation: Intention to treat (ITT) population.
Modification of Diet in Renal Disease (MDRD) formula is: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where * C is the serum concentration of creatinine \[mg/dL\], * A is patient age at sample collection date \[years\], * G=0.742 when gender is female, otherwise G=1, * R=1.21 when race is black, otherwise R=1
Outcome measures
| Measure |
Low-dose Everolimus Group
n=277 Participants
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=279 Participants
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=277 Participants
1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula
|
54.66 mL/min/1.73m^2
Interval -1.6 to
|
51.41 mL/min/1.73m^2
Interval -4.9 to
|
52.24 mL/min/1.73m^2
|
Adverse Events
Low-dose Everolimus Group
Serious events: 176 serious events
Other events: 268 other events
Deaths: 0 deaths
High-dose Everolimus Group
Serious events: 193 serious events
Other events: 272 other events
Deaths: 0 deaths
Control Group
Serious events: 168 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose Everolimus Group
n=274 participants at risk
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=278 participants at risk
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=273 participants at risk
1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Vascular disorders
Essential hypertension
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Vascular disorders
Haematoma
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Vascular disorders
Haemorrhage
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Hypertension
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Vascular disorders
Hypotension
|
0.73%
2/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Anaemia
|
0.73%
2/274 • At 24 month
Safety population
|
2.9%
8/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
3/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.73%
2/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Angina pectoris
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Angina unstable
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Aortic valve incompetence
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Atrial fibrillation
|
0.73%
2/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Cardiac disorders
Atrial flutter
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardiac arrest
|
0.73%
2/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
3/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardiomyopathy
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Cardiac disorders
Mitral valve incompetence
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/274 • At 24 month
Safety population
|
2.2%
6/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Eye disorders
Glaucoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Eye disorders
Photophobia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal distension
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.73%
2/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Colitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Constipation
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
1/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
2.6%
7/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Ileus
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Intestinal ulcer
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Pancreatitis
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Peritonitis
|
1.1%
3/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Sclerosing encapsulating peritonitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.73%
2/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
General disorders
Asthenia
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Chills
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
General disorders
Death
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
General disorders
Generalised oedema
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Hernia obstructive
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Implant site effusion
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Influenza like illness
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Malaise
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Multi-organ failure
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Non-cardiac chest pain
|
0.36%
1/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
General disorders
Oedema peripheral
|
0.36%
1/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
General disorders
Pain
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
General disorders
Pyrexia
|
4.4%
12/274 • At 24 month
Safety population
|
5.8%
16/278 • At 24 month
Safety population
|
4.8%
13/273 • At 24 month
Safety population
|
|
General disorders
Sudden death
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Immune system disorders
Kidney transplant rejection
|
1.8%
5/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
2.6%
7/273 • At 24 month
Safety population
|
|
Immune system disorders
Serum sickness
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Immune system disorders
Transplant rejection
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Abdominal sepsis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Abdominal wall abscess
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Abscess
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Abscess limb
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Acute sinusitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Appendicitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
BK virus infection
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Infections and infestations
Bacteraemia
|
1.5%
4/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Bronchitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Bronchopneumonia
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Cellulitis
|
1.8%
5/274 • At 24 month
Safety population
|
1.8%
5/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
4.0%
11/273 • At 24 month
Safety population
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Device related infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Fungal infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Gastroenteritis
|
2.2%
6/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
3.3%
9/273 • At 24 month
Safety population
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Graft infection
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Infections and infestations
Herpes simplex
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Herpes zoster
|
0.36%
1/274 • At 24 month
Safety population
|
2.2%
6/278 • At 24 month
Safety population
|
1.8%
5/273 • At 24 month
Safety population
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Incision site infection
|
0.00%
0/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Infected skin ulcer
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Infection
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Localised infection
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Necrotising fasciitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Oral herpes
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Osteomyelitis
|
1.1%
3/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Otitis media
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Perinephric abscess
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Infections and infestations
Pneumonia
|
2.9%
8/274 • At 24 month
Safety population
|
4.7%
13/278 • At 24 month
Safety population
|
4.4%
12/273 • At 24 month
Safety population
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Pyelonephritis
|
1.8%
5/274 • At 24 month
Safety population
|
2.2%
6/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Infections and infestations
Pyelonephritis acute
|
0.36%
1/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Renal abscess
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Sepsis
|
1.8%
5/274 • At 24 month
Safety population
|
2.2%
6/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
Infections and infestations
Septic shock
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Sinusitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Skin infection
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Staphylococcal sepsis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Stent related infection
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Subcutaneous abscess
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Tonsillitis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.73%
2/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
Infections and infestations
Urinary tract infection
|
7.3%
20/274 • At 24 month
Safety population
|
7.9%
22/278 • At 24 month
Safety population
|
9.2%
25/273 • At 24 month
Safety population
|
|
Infections and infestations
Urosepsis
|
1.5%
4/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Infections and infestations
Viral infection
|
1.1%
3/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
West Nile viral infection
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Infections and infestations
Wound abscess
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Wound infection
|
1.5%
4/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Infections and infestations
Wound infection staphylococcal
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Infections and infestations
Wound sepsis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
3.3%
9/274 • At 24 month
Safety population
|
1.8%
5/278 • At 24 month
Safety population
|
2.6%
7/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Concussion
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.8%
5/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
0.73%
2/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.73%
2/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
1.1%
3/274 • At 24 month
Safety population
|
1.8%
5/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.1%
3/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.73%
2/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Renal graft loss
|
5.1%
14/274 • At 24 month
Safety population
|
6.5%
18/278 • At 24 month
Safety population
|
3.3%
9/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.73%
2/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
1.8%
5/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Urinary anastomotic leak
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.73%
2/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Investigations
Blood creatine increased
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Blood creatinine increased
|
7.3%
20/274 • At 24 month
Safety population
|
6.8%
19/278 • At 24 month
Safety population
|
8.1%
22/273 • At 24 month
Safety population
|
|
Investigations
Blood phosphorus increased
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Blood potassium increased
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Investigations
Blood pressure increased
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Blood urea increased
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Investigations
Haematocrit decreased
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Hormone level abnormal
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Liver function test abnormal
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Platelet count decreased
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Urine output decreased
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Weight decreased
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
Weight increased
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Investigations
White blood cell count increased
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Acidosis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
7/274 • At 24 month
Safety population
|
1.8%
5/278 • At 24 month
Safety population
|
2.9%
8/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
3/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.73%
2/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
3/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.73%
2/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
3/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.73%
2/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.8%
5/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoproliferative disorder
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primitive neuroectodermal tumour
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Central nervous system lesion
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Convulsion
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Encephalopathy
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Headache
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Hemiparesis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Hypoaesthesia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Lethargy
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Migraine
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Sciatica
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Nervous system disorders
Stupor
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Syncope
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Nervous system disorders
Tremor
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Acute psychosis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Aggression
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Agitation
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Confusional state
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Mania
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Mental status changes
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Haematuria
|
1.8%
5/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Hydronephrosis
|
1.5%
4/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
2.6%
7/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.1%
3/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal failure acute
|
2.2%
6/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
2.6%
7/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal impairment
|
2.6%
7/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal necrosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal tubular atrophy
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.36%
1/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
1.1%
3/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Residual urine
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.36%
1/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urethral disorder
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urinary fistula
|
0.36%
1/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urinary retention
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Urinoma
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar proteinosis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
3/274 • At 24 month
Safety population
|
3.2%
9/278 • At 24 month
Safety population
|
1.8%
5/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.73%
2/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.73%
2/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.73%
2/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.73%
2/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.36%
1/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
6/274 • At 24 month
Safety population
|
1.1%
3/278 • At 24 month
Safety population
|
1.5%
4/273 • At 24 month
Safety population
|
|
Vascular disorders
Lymphocele
|
5.5%
15/274 • At 24 month
Safety population
|
5.4%
15/278 • At 24 month
Safety population
|
2.9%
8/273 • At 24 month
Safety population
|
|
Vascular disorders
Lymphorrhoea
|
0.73%
2/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Vascular disorders
Orthostatic hypotension
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.37%
1/273 • At 24 month
Safety population
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/274 • At 24 month
Safety population
|
0.72%
2/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Steal syndrome
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/274 • At 24 month
Safety population
|
0.36%
1/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Thrombosis
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
|
Vascular disorders
Venous thrombosis limb
|
0.36%
1/274 • At 24 month
Safety population
|
0.00%
0/278 • At 24 month
Safety population
|
0.00%
0/273 • At 24 month
Safety population
|
Other adverse events
| Measure |
Low-dose Everolimus Group
n=274 participants at risk
1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
High-dose Everolimus Group
n=278 participants at risk
3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
Control Group
n=273 participants at risk
1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.
The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
27.4%
75/274 • At 24 month
Safety population
|
30.9%
86/278 • At 24 month
Safety population
|
24.5%
67/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.2%
6/274 • At 24 month
Safety population
|
2.2%
6/278 • At 24 month
Safety population
|
11.0%
30/273 • At 24 month
Safety population
|
|
Blood and lymphatic system disorders
Polycythaemia
|
5.1%
14/274 • At 24 month
Safety population
|
5.0%
14/278 • At 24 month
Safety population
|
4.4%
12/273 • At 24 month
Safety population
|
|
Cardiac disorders
Tachycardia
|
5.8%
16/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
3.3%
9/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
22/274 • At 24 month
Safety population
|
6.1%
17/278 • At 24 month
Safety population
|
8.4%
23/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
13.9%
38/274 • At 24 month
Safety population
|
9.4%
26/278 • At 24 month
Safety population
|
15.8%
43/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
11/274 • At 24 month
Safety population
|
5.8%
16/278 • At 24 month
Safety population
|
12.8%
35/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Constipation
|
39.1%
107/274 • At 24 month
Safety population
|
45.0%
125/278 • At 24 month
Safety population
|
42.5%
116/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
21.5%
59/274 • At 24 month
Safety population
|
18.7%
52/278 • At 24 month
Safety population
|
23.8%
65/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
18/274 • At 24 month
Safety population
|
7.6%
21/278 • At 24 month
Safety population
|
13.9%
38/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
15/274 • At 24 month
Safety population
|
3.2%
9/278 • At 24 month
Safety population
|
4.0%
11/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.6%
10/274 • At 24 month
Safety population
|
6.1%
17/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Nausea
|
31.0%
85/274 • At 24 month
Safety population
|
29.1%
81/278 • At 24 month
Safety population
|
33.3%
91/273 • At 24 month
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
44/274 • At 24 month
Safety population
|
16.5%
46/278 • At 24 month
Safety population
|
23.8%
65/273 • At 24 month
Safety population
|
|
General disorders
Asthenia
|
2.9%
8/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
5.5%
15/273 • At 24 month
Safety population
|
|
General disorders
Fatigue
|
12.0%
33/274 • At 24 month
Safety population
|
8.3%
23/278 • At 24 month
Safety population
|
11.4%
31/273 • At 24 month
Safety population
|
|
General disorders
Oedema
|
8.4%
23/274 • At 24 month
Safety population
|
7.2%
20/278 • At 24 month
Safety population
|
7.0%
19/273 • At 24 month
Safety population
|
|
General disorders
Oedema peripheral
|
48.9%
134/274 • At 24 month
Safety population
|
45.3%
126/278 • At 24 month
Safety population
|
42.5%
116/273 • At 24 month
Safety population
|
|
General disorders
Pyrexia
|
18.6%
51/274 • At 24 month
Safety population
|
19.8%
55/278 • At 24 month
Safety population
|
13.9%
38/273 • At 24 month
Safety population
|
|
Infections and infestations
Herpes zoster
|
4.4%
12/274 • At 24 month
Safety population
|
2.9%
8/278 • At 24 month
Safety population
|
5.1%
14/273 • At 24 month
Safety population
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
19/274 • At 24 month
Safety population
|
9.0%
25/278 • At 24 month
Safety population
|
6.6%
18/273 • At 24 month
Safety population
|
|
Infections and infestations
Sinusitis
|
5.1%
14/274 • At 24 month
Safety population
|
6.8%
19/278 • At 24 month
Safety population
|
4.0%
11/273 • At 24 month
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
19.0%
52/274 • At 24 month
Safety population
|
17.3%
48/278 • At 24 month
Safety population
|
22.0%
60/273 • At 24 month
Safety population
|
|
Infections and infestations
Urinary tract infection
|
22.6%
62/274 • At 24 month
Safety population
|
21.2%
59/278 • At 24 month
Safety population
|
22.0%
60/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
3.6%
10/274 • At 24 month
Safety population
|
5.0%
14/278 • At 24 month
Safety population
|
4.4%
12/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
6.6%
18/274 • At 24 month
Safety population
|
9.7%
27/278 • At 24 month
Safety population
|
6.6%
18/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Incision site pain
|
17.5%
48/274 • At 24 month
Safety population
|
20.1%
56/278 • At 24 month
Safety population
|
16.5%
45/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
7.7%
21/274 • At 24 month
Safety population
|
2.5%
7/278 • At 24 month
Safety population
|
2.6%
7/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
5.8%
16/274 • At 24 month
Safety population
|
3.2%
9/278 • At 24 month
Safety population
|
4.8%
13/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.4%
45/274 • At 24 month
Safety population
|
12.6%
35/278 • At 24 month
Safety population
|
16.1%
44/273 • At 24 month
Safety population
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
5.1%
14/274 • At 24 month
Safety population
|
3.6%
10/278 • At 24 month
Safety population
|
5.9%
16/273 • At 24 month
Safety population
|
|
Investigations
Blood creatinine increased
|
14.6%
40/274 • At 24 month
Safety population
|
13.7%
38/278 • At 24 month
Safety population
|
19.4%
53/273 • At 24 month
Safety population
|
|
Investigations
Urine output decreased
|
5.1%
14/274 • At 24 month
Safety population
|
2.9%
8/278 • At 24 month
Safety population
|
4.0%
11/273 • At 24 month
Safety population
|
|
Investigations
Weight increased
|
8.0%
22/274 • At 24 month
Safety population
|
8.3%
23/278 • At 24 month
Safety population
|
12.1%
33/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
14/274 • At 24 month
Safety population
|
4.7%
13/278 • At 24 month
Safety population
|
4.0%
11/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.4%
12/274 • At 24 month
Safety population
|
7.9%
22/278 • At 24 month
Safety population
|
7.0%
19/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
15.0%
41/274 • At 24 month
Safety population
|
13.7%
38/278 • At 24 month
Safety population
|
9.5%
26/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.9%
19/274 • At 24 month
Safety population
|
6.1%
17/278 • At 24 month
Safety population
|
6.6%
18/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
17.9%
49/274 • At 24 month
Safety population
|
18.3%
51/278 • At 24 month
Safety population
|
12.8%
35/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.5%
37/274 • At 24 month
Safety population
|
14.0%
39/278 • At 24 month
Safety population
|
13.9%
38/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
18.6%
51/274 • At 24 month
Safety population
|
20.5%
57/278 • At 24 month
Safety population
|
16.8%
46/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
20.1%
55/274 • At 24 month
Safety population
|
22.3%
62/278 • At 24 month
Safety population
|
16.1%
44/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
3.3%
9/274 • At 24 month
Safety population
|
2.2%
6/278 • At 24 month
Safety population
|
5.1%
14/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.1%
14/274 • At 24 month
Safety population
|
5.4%
15/278 • At 24 month
Safety population
|
4.8%
13/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.2%
28/274 • At 24 month
Safety population
|
10.8%
30/278 • At 24 month
Safety population
|
8.1%
22/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
17/274 • At 24 month
Safety population
|
4.0%
11/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.5%
37/274 • At 24 month
Safety population
|
16.9%
47/278 • At 24 month
Safety population
|
11.7%
32/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.9%
38/274 • At 24 month
Safety population
|
14.0%
39/278 • At 24 month
Safety population
|
15.8%
43/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.9%
38/274 • At 24 month
Safety population
|
15.8%
44/278 • At 24 month
Safety population
|
13.2%
36/273 • At 24 month
Safety population
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.5%
15/274 • At 24 month
Safety population
|
5.8%
16/278 • At 24 month
Safety population
|
6.2%
17/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
29/274 • At 24 month
Safety population
|
14.0%
39/278 • At 24 month
Safety population
|
11.7%
32/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
35/274 • At 24 month
Safety population
|
7.2%
20/278 • At 24 month
Safety population
|
11.4%
31/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
14/274 • At 24 month
Safety population
|
5.4%
15/278 • At 24 month
Safety population
|
8.8%
24/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
19/274 • At 24 month
Safety population
|
1.4%
4/278 • At 24 month
Safety population
|
4.0%
11/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.8%
16/274 • At 24 month
Safety population
|
4.3%
12/278 • At 24 month
Safety population
|
6.2%
17/273 • At 24 month
Safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.1%
36/274 • At 24 month
Safety population
|
10.4%
29/278 • At 24 month
Safety population
|
12.1%
33/273 • At 24 month
Safety population
|
|
Nervous system disorders
Dizziness
|
6.9%
19/274 • At 24 month
Safety population
|
7.2%
20/278 • At 24 month
Safety population
|
6.6%
18/273 • At 24 month
Safety population
|
|
Nervous system disorders
Headache
|
20.1%
55/274 • At 24 month
Safety population
|
17.6%
49/278 • At 24 month
Safety population
|
16.8%
46/273 • At 24 month
Safety population
|
|
Nervous system disorders
Paraesthesia
|
3.3%
9/274 • At 24 month
Safety population
|
2.9%
8/278 • At 24 month
Safety population
|
5.9%
16/273 • At 24 month
Safety population
|
|
Nervous system disorders
Tremor
|
8.8%
24/274 • At 24 month
Safety population
|
8.3%
23/278 • At 24 month
Safety population
|
13.9%
38/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Anxiety
|
9.9%
27/274 • At 24 month
Safety population
|
6.5%
18/278 • At 24 month
Safety population
|
7.0%
19/273 • At 24 month
Safety population
|
|
Psychiatric disorders
Insomnia
|
18.6%
51/274 • At 24 month
Safety population
|
18.7%
52/278 • At 24 month
Safety population
|
16.8%
46/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Dysuria
|
10.6%
29/274 • At 24 month
Safety population
|
10.1%
28/278 • At 24 month
Safety population
|
11.0%
30/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Haematuria
|
12.4%
34/274 • At 24 month
Safety population
|
8.3%
23/278 • At 24 month
Safety population
|
12.1%
33/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Proteinuria
|
11.3%
31/274 • At 24 month
Safety population
|
13.3%
37/278 • At 24 month
Safety population
|
8.1%
22/273 • At 24 month
Safety population
|
|
Renal and urinary disorders
Renal tubular necrosis
|
5.8%
16/274 • At 24 month
Safety population
|
5.4%
15/278 • At 24 month
Safety population
|
3.7%
10/273 • At 24 month
Safety population
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.0%
11/274 • At 24 month
Safety population
|
5.4%
15/278 • At 24 month
Safety population
|
2.2%
6/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
25/274 • At 24 month
Safety population
|
10.4%
29/278 • At 24 month
Safety population
|
12.8%
35/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
20/274 • At 24 month
Safety population
|
7.6%
21/278 • At 24 month
Safety population
|
10.6%
29/273 • At 24 month
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
17/274 • At 24 month
Safety population
|
5.8%
16/278 • At 24 month
Safety population
|
4.4%
12/273 • At 24 month
Safety population
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.7%
32/274 • At 24 month
Safety population
|
15.1%
42/278 • At 24 month
Safety population
|
9.2%
25/273 • At 24 month
Safety population
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.9%
8/274 • At 24 month
Safety population
|
4.0%
11/278 • At 24 month
Safety population
|
5.5%
15/273 • At 24 month
Safety population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
18/274 • At 24 month
Safety population
|
6.5%
18/278 • At 24 month
Safety population
|
5.9%
16/273 • At 24 month
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
13/274 • At 24 month
Safety population
|
6.1%
17/278 • At 24 month
Safety population
|
6.2%
17/273 • At 24 month
Safety population
|
|
Vascular disorders
Hypertension
|
31.4%
86/274 • At 24 month
Safety population
|
29.9%
83/278 • At 24 month
Safety population
|
31.9%
87/273 • At 24 month
Safety population
|
|
Vascular disorders
Hypotension
|
6.2%
17/274 • At 24 month
Safety population
|
8.6%
24/278 • At 24 month
Safety population
|
9.5%
26/273 • At 24 month
Safety population
|
|
Vascular disorders
Lymphocele
|
3.3%
9/274 • At 24 month
Safety population
|
7.2%
20/278 • At 24 month
Safety population
|
4.4%
12/273 • At 24 month
Safety population
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER