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Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (TRANSFORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01950819
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions End Stage Renal Disease (ESRD)
Chronic Kidney Disease (CKD)
Hemodialysis
Renal Replacement Therapy
Renal Transplantation
Interventions Biological: Induction therapy
Drug: Corticosteroids
Drug: EVR+rCNI
Drug: MPA+sCNI
Enrollment 2037
Recruitment Details The full analysis set consisted of all randomized and transplanted patients. The safet set consisted of all patients who received at least one dose of study drug
Pre-assignment Details 2226 patients screened; 2037 patients transplanted and randomized to treatment.
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus) Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Period Title: Overall Study
Started 1022 1015
Completed 893 881
Not Completed 129 134
Reason Not Completed
Graft Loss             35             30
Death             29             34
Subject / Gardian decision             54             51
technical problems             2             0
Pregnancy             0             2
Lost to Follow-up             9             17
Arm/Group Title EVR+rCNI MPA+sCNI Total
Hide Arm/Group Description Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus) Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus). Total of all reporting groups
Overall Number of Baseline Participants 1022 1015 2037
Hide Baseline Analysis Population Description
Full Analysis set
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1022 participants 1015 participants 2037 participants
48.79  (14.123) 48.75  (14.515) 48.77  (14.316)
[1]
Measure Analysis Population Description: full analysis set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1022 participants 1015 participants 2037 participants
Female
312
  30.5%
308
  30.3%
620
  30.4%
Male
710
  69.5%
707
  69.7%
1417
  69.6%
[1]
Measure Analysis Population Description: full analysis set
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1022 participants 1015 participants 2037 participants
Hispany or Latino
157
  15.4%
132
  13.0%
289
  14.2%
not Hispanic or Latino
646
  63.2%
661
  65.1%
1307
  64.2%
Unknown or not reported
219
  21.4%
222
  21.9%
441
  21.6%
[1]
Measure Description: Ethnicity
[2]
Measure Analysis Population Description: full analysis set
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1022 participants 1015 participants 2037 participants
Caucasian
743
  72.7%
735
  72.4%
1478
  72.6%
Asian
136
  13.3%
157
  15.5%
293
  14.4%
Black
43
   4.2%
35
   3.4%
78
   3.8%
Other
100
   9.8%
88
   8.7%
188
   9.2%
[1]
Measure Description: Race
[2]
Measure Analysis Population Description: full analysis set
1.Primary Outcome
Title Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
Hide Description Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.
Time Frame Month 12 is Primary, Month 24 secondary
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
489
  47.8%
456
  44.9%
month 24
489
  47.8%
443
  43.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EVR+rCNI, MPA+sCNI
Comments calculated at month 12
Type of Statistical Test Non-Inferiority
Comments p vale for non inferiority margin is 10 %
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Logistic Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-1.4 to 7.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
Hide Description Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
146
  14.3%
131
  12.9%
month 24
169
  16.5%
147
  14.5%
3.Secondary Outcome
Title Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
Hide Description Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
497
  48.6%
466
  45.9%
month 24
497
  48.6%
457
  45.0%
4.Secondary Outcome
Title Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
Hide Description Incidence of failure on the composite endpoint of graft loss or death.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
51
   5.0%
54
   5.3%
month 24
67
   6.6%
65
   6.4%
5.Secondary Outcome
Title Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
Hide Description Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
deaths month 12
20
   2.0%
28
   2.8%
deaths month 24
32
   3.1%
36
   3.5%
graft loss month 12
33
   3.2%
28
   2.8%
graft loss month 24
37
   3.6%
32
   3.2%
tBPAR month 12
107
  10.5%
91
   9.0%
tBPAR month 24
118
  11.5%
98
   9.7%
BPAR month 12
114
  11.2%
95
   9.4%
BPAR month 24
127
  12.4%
104
  10.2%
tAR month 12
129
  12.6%
117
  11.5%
tAR month 24
145
  14.2%
126
  12.4%
AR month 12
147
  14.4%
133
  13.1%
AR month 24
167
  16.3%
144
  14.2%
aAMR month 12
73
   7.1%
61
   6.0%
aAMR month 24
84
   8.2%
69
   6.8%
cAMR month 12
9
   0.9%
14
   1.4%
cAMR month 24
13
   1.3%
18
   1.8%
6.Secondary Outcome
Title Incidence of eGFR < 50 mL/Min/1.73m2
Hide Description Incidence of eGFR < 50 mL/min/1.73m2
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
456
  44.6%
424
  41.8%
month 24
474
  46.4%
423
  41.7%
7.Secondary Outcome
Title Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
Hide Description Renal allograft function : mean estimated glomerular filtration rate, eGFR
Time Frame Baseline (week 4), Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Mean (Standard Error)
Unit of Measure: mL/min/1.73m2
baseline (week 4) 53.13  (0.765) 52.25  (0.684)
month 12 53.29  (0.698) 54.49  (0.667)
month 24 52.63  (0.744) 54.91  (0.719)
8.Secondary Outcome
Title Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
Hide Description Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Mean (Standard Error)
Unit of Measure: mL / min / 1.73m2 / day
0.0001  (0.0008) 0.0047  (0.0008)
9.Secondary Outcome
Title Renal Function Assessed by Creatinine Lab Values
Hide Description Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set with measure
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Mean (Standard Deviation)
Unit of Measure: micromol/L
screening baseline (creatinine, micromol/L) Number Analyzed 448 participants 498 participants
590.1  (262.78) 601.8  (265.08)
month 12 (creatinine, micromol/L) Number Analyzed 742 participants 816 participants
129.8  (49.12) 128.6  (50.80)
month 24 (creatinine, micromol/L) Number Analyzed 640 participants 719 participants
130.1  (53.54) 127.6  (52.50)
10.Secondary Outcome
Title Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
Hide Description Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set with measure
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m2
eGFR (Hoek) baseline (mL/min/1.73m2) Number Analyzed 443 participants 493 participants
21.38  (14.296) 20.10  (12.408)
eGFR (Hoek) month 12 (mL/min/1.73m2) Number Analyzed 734 participants 801 participants
50.08  (14.430) 52.00  (14.533)
eGFR (Hoek) month 24 (mL/min/1.73m2) Number Analyzed 641 participants 702 participants
49.86  (14.604) 52.75  (15.406)
eGFR (MDRD4) baseline (mL/min/1.73m2) Number Analyzed 448 participants 498 participants
11.79  (8.697) 11.56  (8.853)
eGFR (MDRD4) month 12 (mL/min/1.73m2) Number Analyzed 742 participants 816 participants
57.59  (19.685) 57.58  (18.768)
eGFR (MDRD4) month 24 (mL/min/1.73m2) Number Analyzed 640 participants 719 participants
58.07  (20.168) 58.68  (19.541)
eGFR-CKDEPI baseline (mL/min/1.73m2) Number Analyzed 448 participants 498 participants
11.29  (9.094) 11.05  (9.195)
eGFR-CKDEPI month 12(mL/min/1.73m2) Number Analyzed 742 participants 816 participants
58.83  (20.686) 58.75  (19.757)
eGFR-CKDEPI month 24 (mL/min/1.73m2) Number Analyzed 640 participants 719 participants
59.39  (21.077) 59.95  (20.652)
11.Secondary Outcome
Title Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
Hide Description Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
safety set 24 months analysis
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1014 1012
Measure Type: Count of Participants
Unit of Measure: Participants
276
  27.2%
152
  15.0%
12.Secondary Outcome
Title Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
Hide Description Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
safety set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1014 1012
Measure Type: Count of Participants
Unit of Measure: Participants
clinical signs of CMV infection
53
   5.2%
132
  13.0%
any BKV infection
103
  10.2%
154
  15.2%
new onset of diabetes mellitus
144
  14.2%
138
  13.6%
at least one event of interest
871
  85.9%
764
  75.5%
13.Secondary Outcome
Title Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
Hide Description Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.
Time Frame Baseline, Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
safety set with measure
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1014 1012
Mean (Standard Deviation)
Unit of Measure: mg/g
albumine /creatinine ratio baseline Number Analyzed 79 participants 54 participants
1019.75  (2737.96) 646.111  (799.234)
albumine /creatinine ratio month 12 Number Analyzed 729 participants 794 participants
150.061  (482.394) 111.322  (444.631)
albumine /creatinine ratio month 24 Number Analyzed 633 participants 708 participants
149.049  (464.470) 116.618  (433.392)
protein /creatinine ratio baseline Number Analyzed 79 participants 54 participants
1648.10  (3768.22) 1142.59  (1003.69)
protein /creatinine ratio month 12 Number Analyzed 729 participants 794 participants
298.557  (642.103) 234.698  (583.632)
protein /creatinine ratio month 24 Number Analyzed 633 participants 708 participants
290.242  (588.119) 233.009  (524.383)
14.Secondary Outcome
Title Incidence of Major Cardiovascular Events.
Hide Description Incidence of major cardiovascular events by Preferred Term
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
safety set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1014 1012
Measure Type: Count of Participants
Unit of Measure: Participants
66
   6.5%
86
   8.5%
15.Secondary Outcome
Title Incidence of Malignancies.
Hide Description Incidence of malignancies.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
safety set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1014 1012
Measure Type: Count of Participants
Unit of Measure: Participants
41
   4.0%
39
   3.9%
16.Secondary Outcome
Title Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
Hide Description Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
compliance set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 187 277
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
60
  32.1%
106
  38.3%
month 24
62
  33.2%
102
  36.8%
17.Secondary Outcome
Title Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
Hide Description

Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:

  • Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IIA - Mild to moderate intimal arteritis
  • Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
  • Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
Patient's maximum tBPAR grade : no grade (missing)
25
   2.4%
18
   1.8%
Patient's maximum tBPAR grade : grade IA
34
   3.3%
36
   3.5%
Patient's maximum tBPAR grade : grade IB
23
   2.3%
17
   1.7%
Patient's maximum tBPAR grade : grade IIA
21
   2.1%
24
   2.4%
Patient's maximum tBPAR grade : grade IIB
9
   0.9%
3
   0.3%
Patient's maximum tBPAR grade : grade III
6
   0.6%
0
   0.0%
18.Secondary Outcome
Title Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
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Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:

  • Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IIA - Mild to moderate intimal arteritis
  • Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
  • Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)
Time Frame Month 12 and 24
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full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
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Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Number
Unit of Measure: events
overall number of tBPAR regardless of grade 146 116
number of tBPAR regardless of grade days 1-90 72 63
number of tBPAR regardless of grade days 91-180 24 14
number of tBPAR regardless of grade days 181-360 25 20
number of tBPAR regardless of grade days 361-540 12 15
number of tBPAR regardless of grade days 541-720 11 2
number of tBPAR regardless of grade days 721-810 2 2
19.Secondary Outcome
Title Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
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Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:

  • Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
  • Type IIA - Mild to moderate intimal arteritis
  • Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
  • Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)
Time Frame Month 12 and 24
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full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
66
   6.5%
53
   5.2%
month 24
74
   7.2%
55
   5.4%
20.Secondary Outcome
Title Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
Hide Description Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup
Time Frame Month 12 and 24
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Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
489
  47.8%
456
  44.9%
month 24
489
  47.8%
443
  43.6%
21.Secondary Outcome
Title Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
Hide Description Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
475
  46.5%
441
  43.4%
month 24
475
  46.5%
426
  42.0%
22.Secondary Outcome
Title Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
Hide Description Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
full analysis set
Arm/Group Title EVR+rCNI MPA+sCNI
Hide Arm/Group Description:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Overall Number of Participants Analyzed 1022 1015
Measure Type: Count of Participants
Unit of Measure: Participants
month 12
181
  17.7%
170
  16.7%
month 24
218
  21.3%
201
  19.8%
Time Frame Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 4 years.
Adverse Event Reporting Description treatment emergent AE / SAE . Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
 
Arm/Group Title Everolimus Plus@Reduced CNI MPA Plus Standard@CNI
Hide Arm/Group Description Everolimus plus@reduced CNI MPA plus standard@CNI
All-Cause Mortality
Everolimus Plus@Reduced CNI MPA Plus Standard@CNI
Affected / at Risk (%) Affected / at Risk (%)
Total   20/1014 (1.97%)   29/1012 (2.87%) 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus Plus@Reduced CNI MPA Plus Standard@CNI
Affected / at Risk (%) Affected / at Risk (%)
Total   593/1014 (58.48%)   613/1012 (60.57%) 
Blood and lymphatic system disorders     
Agranulocytosis  1  2/1014 (0.20%)  0/1012 (0.00%) 
Anaemia  1  14/1014 (1.38%)  6/1012 (0.59%) 
Atypical haemolytic uraemic syndrome  1  1/1014 (0.10%)  0/1012 (0.00%) 
Bone marrow failure  1  0/1014 (0.00%)  1/1012 (0.10%) 
Febrile neutropenia  1  0/1014 (0.00%)  5/1012 (0.49%) 
Granulocytopenia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Haemolysis  1  2/1014 (0.20%)  0/1012 (0.00%) 
Haemolytic uraemic syndrome  1  1/1014 (0.10%)  2/1012 (0.20%) 
Iron deficiency anaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Leukocytosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Leukopenia  1  4/1014 (0.39%)  12/1012 (1.19%) 
Lymphadenopathy  1  1/1014 (0.10%)  0/1012 (0.00%) 
Lymphatic obstruction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Lymphopenia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Nephrogenic anaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Neutropenia  1  1/1014 (0.10%)  6/1012 (0.59%) 
Pancytopenia  1  2/1014 (0.20%)  1/1012 (0.10%) 
Polycythaemia  1  0/1014 (0.00%)  2/1012 (0.20%) 
Sickle cell anaemia with crisis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Splenomegaly  1  0/1014 (0.00%)  1/1012 (0.10%) 
Thrombocytopenia  1  3/1014 (0.30%)  1/1012 (0.10%) 
Thrombotic microangiopathy  1  8/1014 (0.79%)  3/1012 (0.30%) 
Cardiac disorders     
Acute coronary syndrome  1  4/1014 (0.39%)  2/1012 (0.20%) 
Acute myocardial infarction  1  6/1014 (0.59%)  6/1012 (0.59%) 
Angina pectoris  1  6/1014 (0.59%)  5/1012 (0.49%) 
Angina unstable  1  1/1014 (0.10%)  1/1012 (0.10%) 
Aortic valve stenosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Arrhythmia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Arrhythmia supraventricular  1  1/1014 (0.10%)  0/1012 (0.00%) 
Arteriosclerosis coronary artery  1  0/1014 (0.00%)  2/1012 (0.20%) 
Atrial fibrillation  1  12/1014 (1.18%)  12/1012 (1.19%) 
Atrial flutter  1  4/1014 (0.39%)  1/1012 (0.10%) 
Bradycardia  1  3/1014 (0.30%)  1/1012 (0.10%) 
Cardiac arrest  1  4/1014 (0.39%)  4/1012 (0.40%) 
Cardiac asthma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cardiac dysfunction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cardiac failure  1  9/1014 (0.89%)  7/1012 (0.69%) 
Cardiac failure acute  1  2/1014 (0.20%)  0/1012 (0.00%) 
Cardiac failure chronic  1  2/1014 (0.20%)  1/1012 (0.10%) 
Cardiac failure congestive  1  6/1014 (0.59%)  3/1012 (0.30%) 
Cardio-respiratory arrest  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cardiorenal syndrome  1  1/1014 (0.10%)  0/1012 (0.00%) 
Coronary artery disease  1  2/1014 (0.20%)  6/1012 (0.59%) 
Coronary artery insufficiency  1  0/1014 (0.00%)  1/1012 (0.10%) 
Coronary artery stenosis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Hypertensive heart disease  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ischaemic cardiomyopathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Left ventricular failure  1  1/1014 (0.10%)  0/1012 (0.00%) 
Left ventricular hypertrophy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Myocardial infarction  1  5/1014 (0.49%)  6/1012 (0.59%) 
Myocardial ischaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pericarditis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pericarditis constrictive  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pulseless electrical activity  1  0/1014 (0.00%)  1/1012 (0.10%) 
Tachycardia  1  0/1014 (0.00%)  2/1012 (0.20%) 
Ventricular extrasystoles  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ventricular tachyarrhythmia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ventricular tachycardia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Congenital, familial and genetic disorders     
Arteriovenous malformation  1  0/1014 (0.00%)  1/1012 (0.10%) 
Congenital cystic kidney disease  1  0/1014 (0.00%)  1/1012 (0.10%) 
Congenital megaureter  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hydrocele  1  1/1014 (0.10%)  2/1012 (0.20%) 
Tracheo-oesophageal fistula  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ear and labyrinth disorders     
Mastoid effusion  1  1/1014 (0.10%)  0/1012 (0.00%) 
Sudden hearing loss  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tinnitus  1  0/1014 (0.00%)  1/1012 (0.10%) 
Vertigo  1  1/1014 (0.10%)  0/1012 (0.00%) 
Endocrine disorders     
Goitre  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hyperparathyroidism  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hyperparathyroidism tertiary  1  0/1014 (0.00%)  1/1012 (0.10%) 
Eye disorders     
Cataract  1  1/1014 (0.10%)  3/1012 (0.30%) 
Glaucoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Optic ischaemic neuropathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Retinal detachment  1  0/1014 (0.00%)  1/1012 (0.10%) 
Vision blurred  1  0/1014 (0.00%)  1/1012 (0.10%) 
Visual acuity reduced  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastrointestinal disorders     
Abdominal hernia  1  4/1014 (0.39%)  2/1012 (0.20%) 
Abdominal pain  1  9/1014 (0.89%)  14/1012 (1.38%) 
Abdominal pain lower  1  1/1014 (0.10%)  1/1012 (0.10%) 
Abdominal pain upper  1  4/1014 (0.39%)  3/1012 (0.30%) 
Abdominal wall haematoma  1  1/1014 (0.10%)  1/1012 (0.10%) 
Acute abdomen  1  1/1014 (0.10%)  0/1012 (0.00%) 
Anal polyp  1  1/1014 (0.10%)  0/1012 (0.00%) 
Anogenital dysplasia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Barrett's oesophagus  1  1/1014 (0.10%)  0/1012 (0.00%) 
Chronic gastritis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Colitis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Colitis ischaemic  1  1/1014 (0.10%)  0/1012 (0.00%) 
Colitis ulcerative  1  0/1014 (0.00%)  1/1012 (0.10%) 
Constipation  1  1/1014 (0.10%)  3/1012 (0.30%) 
Crohn's disease  1  1/1014 (0.10%)  1/1012 (0.10%) 
Diabetic gastroparesis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Diarrhoea  1  27/1014 (2.66%)  55/1012 (5.43%) 
Diverticulum  1  1/1014 (0.10%)  0/1012 (0.00%) 
Diverticulum intestinal  1  1/1014 (0.10%)  0/1012 (0.00%) 
Diverticulum intestinal haemorrhagic  1  0/1014 (0.00%)  2/1012 (0.20%) 
Duodenal perforation  1  0/1014 (0.00%)  1/1012 (0.10%) 
Duodenal ulcer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Encapsulating peritoneal sclerosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Enteritis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Enterocolitis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Food poisoning  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastric haemorrhage  1  1/1014 (0.10%)  0/1012 (0.00%) 
Gastric ulcer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastritis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Gastritis erosive  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastritis haemorrhagic  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastrointestinal fistula  1  1/1014 (0.10%)  0/1012 (0.00%) 
Gastrointestinal haemorrhage  1  2/1014 (0.20%)  4/1012 (0.40%) 
Gastrooesophageal reflux disease  1  0/1014 (0.00%)  1/1012 (0.10%) 
Haematochezia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Haemorrhoidal haemorrhage  1  1/1014 (0.10%)  0/1012 (0.00%) 
Haemorrhoids  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hernial eventration  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hiatus hernia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ileus  1  5/1014 (0.49%)  2/1012 (0.20%) 
Impaired gastric emptying  1  1/1014 (0.10%)  1/1012 (0.10%) 
Inguinal hernia  1  2/1014 (0.20%)  5/1012 (0.49%) 
Intestinal obstruction  1  2/1014 (0.20%)  2/1012 (0.20%) 
Intestinal perforation  1  2/1014 (0.20%)  1/1012 (0.10%) 
Intra-abdominal fluid collection  1  5/1014 (0.49%)  1/1012 (0.10%) 
Intra-abdominal haematoma  1  2/1014 (0.20%)  1/1012 (0.10%) 
Intra-abdominal haemorrhage  1  1/1014 (0.10%)  0/1012 (0.00%) 
Large intestine perforation  1  1/1014 (0.10%)  0/1012 (0.00%) 
Large intestine polyp  1  1/1014 (0.10%)  0/1012 (0.00%) 
Lumbar hernia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Mallory-Weiss syndrome  1  1/1014 (0.10%)  0/1012 (0.00%) 
Melaena  1  0/1014 (0.00%)  1/1012 (0.10%) 
Mouth ulceration  1  1/1014 (0.10%)  2/1012 (0.20%) 
Nausea  1  3/1014 (0.30%)  9/1012 (0.89%) 
Oesophageal achalasia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Oesophageal spasm  1  0/1014 (0.00%)  1/1012 (0.10%) 
Oesophagitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pancreatitis  1  1/1014 (0.10%)  2/1012 (0.20%) 
Pancreatitis acute  1  0/1014 (0.00%)  2/1012 (0.20%) 
Pancreatitis chronic  1  0/1014 (0.00%)  1/1012 (0.10%) 
Rectal haemorrhage  1  0/1014 (0.00%)  2/1012 (0.20%) 
Retching  1  0/1014 (0.00%)  1/1012 (0.10%) 
Retroperitoneal haematoma  1  2/1014 (0.20%)  5/1012 (0.49%) 
Retroperitoneal haemorrhage  1  0/1014 (0.00%)  1/1012 (0.10%) 
Salivary gland enlargement  1  1/1014 (0.10%)  0/1012 (0.00%) 
Small intestinal obstruction  1  2/1014 (0.20%)  4/1012 (0.40%) 
Stomatitis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Umbilical hernia  1  3/1014 (0.30%)  0/1012 (0.00%) 
Volvulus  1  1/1014 (0.10%)  0/1012 (0.00%) 
Volvulus of small bowel  1  1/1014 (0.10%)  0/1012 (0.00%) 
Vomiting  1  6/1014 (0.59%)  13/1012 (1.28%) 
General disorders     
Asthenia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Catheter site haemorrhage  1  1/1014 (0.10%)  0/1012 (0.00%) 
Chest discomfort  1  1/1014 (0.10%)  0/1012 (0.00%) 
Chest pain  1  1/1014 (0.10%)  2/1012 (0.20%) 
Chills  1  1/1014 (0.10%)  2/1012 (0.20%) 
Death  1  0/1014 (0.00%)  2/1012 (0.20%) 
Fatigue  1  2/1014 (0.20%)  2/1012 (0.20%) 
Gait inability  1  0/1014 (0.00%)  1/1012 (0.10%) 
General physical health deterioration  1  0/1014 (0.00%)  1/1012 (0.10%) 
Generalised oedema  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hyperthermia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypothermia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ill-defined disorder  1  0/1014 (0.00%)  1/1012 (0.10%) 
Impaired healing  1  10/1014 (0.99%)  1/1012 (0.10%) 
Malaise  1  2/1014 (0.20%)  1/1012 (0.10%) 
Medical device site discomfort  1  1/1014 (0.10%)  0/1012 (0.00%) 
Medical device site inflammation  1  1/1014 (0.10%)  0/1012 (0.00%) 
Microlithiasis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Multiple organ dysfunction syndrome  1  1/1014 (0.10%)  0/1012 (0.00%) 
Non-cardiac chest pain  1  1/1014 (0.10%)  2/1012 (0.20%) 
Oedema peripheral  1  7/1014 (0.69%)  4/1012 (0.40%) 
Pain  1  0/1014 (0.00%)  1/1012 (0.10%) 
Peripheral swelling  1  0/1014 (0.00%)  2/1012 (0.20%) 
Pyrexia  1  35/1014 (3.45%)  36/1012 (3.56%) 
Sudden death  1  1/1014 (0.10%)  0/1012 (0.00%) 
Suprapubic pain  1  0/1014 (0.00%)  1/1012 (0.10%) 
Swelling  1  0/1014 (0.00%)  1/1012 (0.10%) 
Systemic inflammatory response syndrome  1  1/1014 (0.10%)  2/1012 (0.20%) 
Hepatobiliary disorders     
Bile duct stone  1  1/1014 (0.10%)  0/1012 (0.00%) 
Biliary colic  1  0/1014 (0.00%)  1/1012 (0.10%) 
Biliary dilatation  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cholangitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cholecystitis  1  2/1014 (0.20%)  3/1012 (0.30%) 
Cholecystitis acute  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cholelithiasis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Cholestasis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hepatocellular injury  1  0/1014 (0.00%)  1/1012 (0.10%) 
Perforation bile duct  1  0/1014 (0.00%)  1/1012 (0.10%) 
Immune system disorders     
Anaphylactic reaction  1  0/1014 (0.00%)  1/1012 (0.10%) 
Chronic allograft nephropathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hypersensitivity  1  0/1014 (0.00%)  1/1012 (0.10%) 
Immunosuppression  1  1/1014 (0.10%)  0/1012 (0.00%) 
Kidney transplant rejection  1  18/1014 (1.78%)  17/1012 (1.68%) 
Renal transplant failure  1  4/1014 (0.39%)  5/1012 (0.49%) 
Transplant rejection  1  45/1014 (4.44%)  25/1012 (2.47%) 
Infections and infestations     
Abdominal abscess  1  1/1014 (0.10%)  1/1012 (0.10%) 
Abdominal infection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Actinomycosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Adenoviral haemorrhagic cystitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Adenovirus infection  1  2/1014 (0.20%)  1/1012 (0.10%) 
Anal abscess  1  1/1014 (0.10%)  1/1012 (0.10%) 
Appendicitis  1  0/1014 (0.00%)  3/1012 (0.30%) 
Arteriovenous fistula site infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Arthritis bacterial  1  0/1014 (0.00%)  1/1012 (0.10%) 
Arthritis infective  1  1/1014 (0.10%)  0/1012 (0.00%) 
Asymptomatic bacteriuria  1  1/1014 (0.10%)  0/1012 (0.00%) 
Atypical pneumonia  1  2/1014 (0.20%)  0/1012 (0.00%) 
BK virus infection  1  3/1014 (0.30%)  5/1012 (0.49%) 
Bacteraemia  1  3/1014 (0.30%)  0/1012 (0.00%) 
Bacterial diarrhoea  1  0/1014 (0.00%)  1/1012 (0.10%) 
Bacterial infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Bacterial prostatitis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Bacterial pyelonephritis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Bacterial sepsis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Bacteriuria  1  0/1014 (0.00%)  2/1012 (0.20%) 
Blister infected  1  0/1014 (0.00%)  1/1012 (0.10%) 
Bronchitis  1  2/1014 (0.20%)  3/1012 (0.30%) 
Bronchopulmonary aspergillosis  1  1/1014 (0.10%)  2/1012 (0.20%) 
Campylobacter gastroenteritis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Candida infection  1  2/1014 (0.20%)  0/1012 (0.00%) 
Candiduria  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cellulitis  1  5/1014 (0.49%)  6/1012 (0.59%) 
Chest wall abscess  1  0/1014 (0.00%)  1/1012 (0.10%) 
Chronic sinusitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Chronic tonsillitis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Clostridium difficile colitis  1  4/1014 (0.39%)  3/1012 (0.30%) 
Clostridium difficile infection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Corona virus infection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cryptococcosis  1  0/1014 (0.00%)  3/1012 (0.30%) 
Cystitis viral  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cytomegalovirus colitis  1  0/1014 (0.00%)  9/1012 (0.89%) 
Cytomegalovirus enteritis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cytomegalovirus gastroenteritis  1  0/1014 (0.00%)  3/1012 (0.30%) 
Cytomegalovirus gastrointestinal infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cytomegalovirus hepatitis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Cytomegalovirus infection  1  6/1014 (0.59%)  48/1012 (4.74%) 
Dengue fever  1  1/1014 (0.10%)  0/1012 (0.00%) 
Dermatophytosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Device related infection  1  1/1014 (0.10%)  3/1012 (0.30%) 
Device related sepsis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Diabetic foot infection  1  1/1014 (0.10%)  2/1012 (0.20%) 
Diarrhoea infectious  1  1/1014 (0.10%)  0/1012 (0.00%) 
Disseminated tuberculosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Diverticulitis  1  3/1014 (0.30%)  3/1012 (0.30%) 
Ear infection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Encephalitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Endocarditis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Enteritis infectious  1  1/1014 (0.10%)  0/1012 (0.00%) 
Enterococcal infection  1  1/1014 (0.10%)  1/1012 (0.10%) 
Enterococcal sepsis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Enterocolitis viral  1  1/1014 (0.10%)  0/1012 (0.00%) 
Epididymitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Erysipelas  1  3/1014 (0.30%)  0/1012 (0.00%) 
Escherichia bacteraemia  1  0/1014 (0.00%)  2/1012 (0.20%) 
Escherichia infection  1  1/1014 (0.10%)  1/1012 (0.10%) 
Escherichia pyelonephritis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Escherichia sepsis  1  5/1014 (0.49%)  1/1012 (0.10%) 
Escherichia urinary tract infection  1  1/1014 (0.10%)  7/1012 (0.69%) 
Febrile infection  1  1/1014 (0.10%)  1/1012 (0.10%) 
Fungal infection  1  1/1014 (0.10%)  1/1012 (0.10%) 
Fungal sepsis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Gangrene  1  1/1014 (0.10%)  2/1012 (0.20%) 
Gastroenteritis  1  18/1014 (1.78%)  23/1012 (2.27%) 
Gastroenteritis clostridial  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastroenteritis cryptosporidial  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastroenteritis norovirus  1  0/1014 (0.00%)  6/1012 (0.59%) 
Gastroenteritis viral  1  1/1014 (0.10%)  3/1012 (0.30%) 
Gastrointestinal infection  1  2/1014 (0.20%)  1/1012 (0.10%) 
Groin abscess  1  3/1014 (0.30%)  2/1012 (0.20%) 
HIV infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Haematoma infection  1  2/1014 (0.20%)  0/1012 (0.00%) 
Hepatic cyst infection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hepatitis C  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hepatitis E  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hepatitis viral  1  0/1014 (0.00%)  1/1012 (0.10%) 
Herpes simplex  1  1/1014 (0.10%)  1/1012 (0.10%) 
Herpes simplex pneumonia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Herpes zoster  1  5/1014 (0.49%)  4/1012 (0.40%) 
Herpes zoster disseminated  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ileal gangrene  1  0/1014 (0.00%)  1/1012 (0.10%) 
Infected lymphocele  1  4/1014 (0.39%)  1/1012 (0.10%) 
Infected seroma  1  1/1014 (0.10%)  1/1012 (0.10%) 
Infected skin ulcer  1  3/1014 (0.30%)  2/1012 (0.20%) 
Infection  1  2/1014 (0.20%)  1/1012 (0.10%) 
Infectious colitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Infectious pleural effusion  1  1/1014 (0.10%)  0/1012 (0.00%) 
Influenza  1  6/1014 (0.59%)  5/1012 (0.49%) 
Intervertebral discitis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Intestinal sepsis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Kidney infection  1  1/1014 (0.10%)  2/1012 (0.20%) 
Klebsiella bacteraemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Klebsiella sepsis  1  2/1014 (0.20%)  0/1012 (0.00%) 
Lower respiratory tract infection  1  1/1014 (0.10%)  3/1012 (0.30%) 
Lung infection  1  1/1014 (0.10%)  2/1012 (0.20%) 
Medical device site cellulitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Medical device site infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Meningitis bacterial  1  1/1014 (0.10%)  0/1012 (0.00%) 
Meningitis cryptococcal  1  1/1014 (0.10%)  0/1012 (0.00%) 
Nasopharyngitis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Neutropenic sepsis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Nocardiosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Oral candidiasis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Oral herpes  1  1/1014 (0.10%)  1/1012 (0.10%) 
Orchitis  1  1/1014 (0.10%)  3/1012 (0.30%) 
Osteomyelitis  1  5/1014 (0.49%)  2/1012 (0.20%) 
Osteomyelitis chronic  1  2/1014 (0.20%)  0/1012 (0.00%) 
Parvovirus B19 infection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Perinephric abscess  1  2/1014 (0.20%)  0/1012 (0.00%) 
Peritonitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Peritonsillar abscess  1  1/1014 (0.10%)  1/1012 (0.10%) 
Pharyngotonsillitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pneumococcal sepsis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pneumocystis jirovecii pneumonia  1  6/1014 (0.59%)  3/1012 (0.30%) 
Pneumonia  1  55/1014 (5.42%)  36/1012 (3.56%) 
Pneumonia bacterial  1  1/1014 (0.10%)  1/1012 (0.10%) 
Pneumonia cryptococcal  1  0/1014 (0.00%)  2/1012 (0.20%) 
Pneumonia cytomegaloviral  1  1/1014 (0.10%)  4/1012 (0.40%) 
Pneumonia fungal  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pneumonia haemophilus  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pneumonia influenzal  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pneumonia legionella  1  1/1014 (0.10%)  1/1012 (0.10%) 
Polyomavirus-associated nephropathy  1  4/1014 (0.39%)  10/1012 (0.99%) 
Postoperative abscess  1  0/1014 (0.00%)  1/1012 (0.10%) 
Postoperative wound infection  1  3/1014 (0.30%)  3/1012 (0.30%) 
Pseudomembranous colitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pseudomonal bacteraemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pseudomonal sepsis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pulmonary tuberculosis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Pyelonephritis  1  24/1014 (2.37%)  33/1012 (3.26%) 
Pyelonephritis acute  1  6/1014 (0.59%)  13/1012 (1.28%) 
Pyelonephritis chronic  1  1/1014 (0.10%)  1/1012 (0.10%) 
Pyuria  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal cyst infection  1  1/1014 (0.10%)  3/1012 (0.30%) 
Renal graft infection  1  2/1014 (0.20%)  0/1012 (0.00%) 
Respiratory tract infection  1  5/1014 (0.49%)  5/1012 (0.49%) 
Respiratory tract infection fungal  1  0/1014 (0.00%)  1/1012 (0.10%) 
Respiratory tract infection viral  1  0/1014 (0.00%)  1/1012 (0.10%) 
Rhinitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Rhinovirus infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Salmonellosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Sepsis  1  20/1014 (1.97%)  7/1012 (0.69%) 
Septic shock  1  6/1014 (0.59%)  8/1012 (0.79%) 
Sinusitis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Sinusitis fungal  1  0/1014 (0.00%)  1/1012 (0.10%) 
Staphylococcal bacteraemia  1  1/1014 (0.10%)  1/1012 (0.10%) 
Streptococcal sepsis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Subcutaneous abscess  1  2/1014 (0.20%)  0/1012 (0.00%) 
Systemic candida  1  0/1014 (0.00%)  1/1012 (0.10%) 
Tonsillitis bacterial  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tooth abscess  1  0/1014 (0.00%)  1/1012 (0.10%) 
Tracheobronchitis  1  1/1014 (0.10%)  1/1012 (0.10%) 
Transplant abscess  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tuberculosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tuberculosis gastrointestinal  1  0/1014 (0.00%)  1/1012 (0.10%) 
Upper respiratory tract infection  1  5/1014 (0.49%)  4/1012 (0.40%) 
Urinary tract infection  1  78/1014 (7.69%)  93/1012 (9.19%) 
Urinary tract infection bacterial  1  4/1014 (0.39%)  1/1012 (0.10%) 
Urinary tract infection enterococcal  1  1/1014 (0.10%)  0/1012 (0.00%) 
Urinary tract infection fungal  1  0/1014 (0.00%)  1/1012 (0.10%) 
Urosepsis  1  23/1014 (2.27%)  23/1012 (2.27%) 
Varicella  1  0/1014 (0.00%)  1/1012 (0.10%) 
Viral diarrhoea  1  1/1014 (0.10%)  1/1012 (0.10%) 
Viral infection  1  2/1014 (0.20%)  2/1012 (0.20%) 
Viral myocarditis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Viral upper respiratory tract infection  1  1/1014 (0.10%)  1/1012 (0.10%) 
Vulvovaginal mycotic infection  1  0/1014 (0.00%)  1/1012 (0.10%) 
Wound abscess  1  1/1014 (0.10%)  0/1012 (0.00%) 
Wound infection  1  5/1014 (0.49%)  4/1012 (0.40%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/1014 (0.10%)  0/1012 (0.00%) 
Anaemia postoperative  1  1/1014 (0.10%)  0/1012 (0.00%) 
Anaesthetic complication  1  1/1014 (0.10%)  0/1012 (0.00%) 
Anastomotic haemorrhage  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ankle fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Aponeurosis contusion  1  0/1014 (0.00%)  3/1012 (0.30%) 
Arterial injury  1  1/1014 (0.10%)  0/1012 (0.00%) 
Arteriovenous fistula aneurysm  1  1/1014 (0.10%)  3/1012 (0.30%) 
Arteriovenous fistula site complication  1  1/1014 (0.10%)  4/1012 (0.40%) 
Arteriovenous fistula thrombosis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Avulsion fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Complications of transplant surgery  1  1/1014 (0.10%)  1/1012 (0.10%) 
Complications of transplanted kidney  1  34/1014 (3.35%)  28/1012 (2.77%) 
Contusion  1  0/1014 (0.00%)  1/1012 (0.10%) 
Coronary bypass stenosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Delayed graft function  1  7/1014 (0.69%)  2/1012 (0.20%) 
Fall  1  1/1014 (0.10%)  1/1012 (0.10%) 
Femoral neck fracture  1  2/1014 (0.20%)  1/1012 (0.10%) 
Femur fracture  1  2/1014 (0.20%)  0/1012 (0.00%) 
Forearm fracture  1  0/1014 (0.00%)  1/1012 (0.10%) 
Graft complication  1  2/1014 (0.20%)  3/1012 (0.30%) 
Graft haemorrhage  1  1/1014 (0.10%)  1/1012 (0.10%) 
Graft loss  1  16/1014 (1.58%)  12/1012 (1.19%) 
Graft thrombosis  1  2/1014 (0.20%)  0/1012 (0.00%) 
Humerus fracture  1  1/1014 (0.10%)  1/1012 (0.10%) 
Incision site complication  1  0/1014 (0.00%)  1/1012 (0.10%) 
Incisional hernia  1  8/1014 (0.79%)  1/1012 (0.10%) 
Injury  1  1/1014 (0.10%)  0/1012 (0.00%) 
Joint dislocation  1  1/1014 (0.10%)  0/1012 (0.00%) 
Laceration  1  1/1014 (0.10%)  0/1012 (0.00%) 
Limb injury  1  0/1014 (0.00%)  1/1012 (0.10%) 
Lower limb fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Lumbar vertebral fracture  1  0/1014 (0.00%)  1/1012 (0.10%) 
Muscle strain  1  0/1014 (0.00%)  1/1012 (0.10%) 
Musculoskeletal injury  1  0/1014 (0.00%)  1/1012 (0.10%) 
Overdose  1  0/1014 (0.00%)  3/1012 (0.30%) 
Pelvic fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Peripheral arterial reocclusion  1  0/1014 (0.00%)  1/1012 (0.10%) 
Perirenal haematoma  1  1/1014 (0.10%)  1/1012 (0.10%) 
Post procedural complication  1  3/1014 (0.30%)  1/1012 (0.10%) 
Post procedural discharge  1  0/1014 (0.00%)  1/1012 (0.10%) 
Post procedural haematoma  1  3/1014 (0.30%)  1/1012 (0.10%) 
Post procedural haematuria  1  2/1014 (0.20%)  1/1012 (0.10%) 
Post procedural haemorrhage  1  4/1014 (0.39%)  4/1012 (0.40%) 
Post procedural persistent drain fluid  1  1/1014 (0.10%)  1/1012 (0.10%) 
Post procedural urine leak  1  0/1014 (0.00%)  1/1012 (0.10%) 
Postoperative fever  1  1/1014 (0.10%)  0/1012 (0.00%) 
Postoperative hernia  1  2/1014 (0.20%)  1/1012 (0.10%) 
Procedural haemorrhage  1  1/1014 (0.10%)  1/1012 (0.10%) 
Radius fracture  1  1/1014 (0.10%)  2/1012 (0.20%) 
Renal lymphocele  1  3/1014 (0.30%)  1/1012 (0.10%) 
Renal transplant torsion  1  1/1014 (0.10%)  0/1012 (0.00%) 
Rib fracture  1  1/1014 (0.10%)  1/1012 (0.10%) 
Scar  1  1/1014 (0.10%)  0/1012 (0.00%) 
Scrotal haematoma  1  0/1014 (0.00%)  2/1012 (0.20%) 
Seroma  1  5/1014 (0.49%)  2/1012 (0.20%) 
Shunt aneurysm  1  2/1014 (0.20%)  1/1012 (0.10%) 
Shunt stenosis  1  2/1014 (0.20%)  0/1012 (0.00%) 
Spinal fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Stress fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Subarachnoid haemorrhage  1  2/1014 (0.20%)  1/1012 (0.10%) 
Subcutaneous haematoma  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tendon rupture  1  2/1014 (0.20%)  3/1012 (0.30%) 
Tibia fracture  1  0/1014 (0.00%)  2/1012 (0.20%) 
Toxicity to various agents  1  5/1014 (0.49%)  4/1012 (0.40%) 
Transplant dysfunction  1  7/1014 (0.69%)  7/1012 (0.69%) 
Transplant failure  1  1/1014 (0.10%)  1/1012 (0.10%) 
Transplantation complication  1  5/1014 (0.49%)  1/1012 (0.10%) 
Traumatic fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ulna fracture  1  1/1014 (0.10%)  0/1012 (0.00%) 
Upper limb fracture  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ureteric anastomosis complication  1  1/1014 (0.10%)  1/1012 (0.10%) 
Urinary anastomotic leak  1  1/1014 (0.10%)  1/1012 (0.10%) 
Vaccination complication  1  1/1014 (0.10%)  0/1012 (0.00%) 
Vascular graft complication  1  1/1014 (0.10%)  1/1012 (0.10%) 
Vascular graft stenosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Vascular graft thrombosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Vascular pseudoaneurysm  1  1/1014 (0.10%)  0/1012 (0.00%) 
Wound decomposition  1  1/1014 (0.10%)  0/1012 (0.00%) 
Wound dehiscence  1  10/1014 (0.99%)  3/1012 (0.30%) 
Wound secretion  1  1/1014 (0.10%)  0/1012 (0.00%) 
Wrist fracture  1  0/1014 (0.00%)  1/1012 (0.10%) 
Investigations     
Alanine aminotransferase increased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Anticoagulation drug level above therapeutic  1  1/1014 (0.10%)  0/1012 (0.00%) 
Aspartate aminotransferase increased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Biopsy kidney  1  1/1014 (0.10%)  0/1012 (0.00%) 
Blood creatine increased  1  2/1014 (0.20%)  3/1012 (0.30%) 
Blood creatinine abnormal  1  1/1014 (0.10%)  2/1012 (0.20%) 
Blood creatinine increased  1  50/1014 (4.93%)  36/1012 (3.56%) 
Blood glucose increased  1  1/1014 (0.10%)  0/1012 (0.00%) 
Blood phosphorus decreased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Blood urea increased  1  1/1014 (0.10%)  0/1012 (0.00%) 
C-reactive protein increased  1  2/1014 (0.20%)  0/1012 (0.00%) 
Catheterisation cardiac  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ejection fraction abnormal  1  0/1014 (0.00%)  1/1012 (0.10%) 
Electrocardiogram T wave inversion  1  0/1014 (0.00%)  1/1012 (0.10%) 
Haemoglobin decreased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Haptoglobin decreased  1  1/1014 (0.10%)  0/1012 (0.00%) 
Immunosuppressant drug level increased  1  1/1014 (0.10%)  0/1012 (0.00%) 
Inflammatory marker increased  1  1/1014 (0.10%)  2/1012 (0.20%) 
Liver function test increased  1  1/1014 (0.10%)  0/1012 (0.00%) 
Norovirus test positive  1  1/1014 (0.10%)  0/1012 (0.00%) 
Occult blood positive  1  1/1014 (0.10%)  0/1012 (0.00%) 
Polyomavirus test positive  1  0/1014 (0.00%)  1/1012 (0.10%) 
Transaminases increased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Troponin increased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Urine output decreased  1  3/1014 (0.30%)  0/1012 (0.00%) 
Weight decreased  1  0/1014 (0.00%)  1/1012 (0.10%) 
Metabolism and nutrition disorders     
Cachexia  1  0/1014 (0.00%)  2/1012 (0.20%) 
Calciphylaxis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Decreased appetite  1  2/1014 (0.20%)  2/1012 (0.20%) 
Dehydration  1  6/1014 (0.59%)  11/1012 (1.09%) 
Diabetes mellitus  1  9/1014 (0.89%)  10/1012 (0.99%) 
Diabetes mellitus inadequate control  1  1/1014 (0.10%)  2/1012 (0.20%) 
Diabetic ketoacidosis  1  3/1014 (0.30%)  2/1012 (0.20%) 
Electrolyte imbalance  1  1/1014 (0.10%)  0/1012 (0.00%) 
Fluid overload  1  5/1014 (0.49%)  3/1012 (0.30%) 
Fluid retention  1  1/1014 (0.10%)  0/1012 (0.00%) 
Gout  1  1/1014 (0.10%)  1/1012 (0.10%) 
Hypercalcaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hyperglycaemia  1  5/1014 (0.49%)  6/1012 (0.59%) 
Hyperkalaemia  1  11/1014 (1.08%)  10/1012 (0.99%) 
Hyperlipidaemia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypertriglyceridaemia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypervolaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hypocalcaemia  1  2/1014 (0.20%)  1/1012 (0.10%) 
Hypoglycaemia  1  0/1014 (0.00%)  5/1012 (0.49%) 
Hypokalaemia  1  3/1014 (0.30%)  0/1012 (0.00%) 
Hypomagnesaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hyponatraemia  1  1/1014 (0.10%)  5/1012 (0.49%) 
Hypophosphataemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hypovolaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Iron deficiency  1  0/1014 (0.00%)  1/1012 (0.10%) 
Malnutrition  1  0/1014 (0.00%)  1/1012 (0.10%) 
Metabolic acidosis  1  0/1014 (0.00%)  4/1012 (0.40%) 
Type 1 diabetes mellitus  1  0/1014 (0.00%)  1/1012 (0.10%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/1014 (0.20%)  2/1012 (0.20%) 
Back pain  1  3/1014 (0.30%)  1/1012 (0.10%) 
Flank pain  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gouty arthritis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Groin pain  1  0/1014 (0.00%)  1/1012 (0.10%) 
Intervertebral disc protrusion  1  2/1014 (0.20%)  1/1012 (0.10%) 
Intervertebral disc space narrowing  1  0/1014 (0.00%)  1/1012 (0.10%) 
Lumbar spinal stenosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Muscular weakness  1  2/1014 (0.20%)  2/1012 (0.20%) 
Musculoskeletal pain  1  1/1014 (0.10%)  1/1012 (0.10%) 
Myalgia intercostal  1  1/1014 (0.10%)  0/1012 (0.00%) 
Osteitis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Osteoarthritis  1  4/1014 (0.39%)  2/1012 (0.20%) 
Osteonecrosis  1  9/1014 (0.89%)  1/1012 (0.10%) 
Pain in extremity  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pubic pain  1  1/1014 (0.10%)  0/1012 (0.00%) 
Sacroiliitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Spinal column stenosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Spinal osteoarthritis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Synovial cyst  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tendonitis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/1014 (0.10%)  0/1012 (0.00%) 
Adenocarcinoma pancreas  1  0/1014 (0.00%)  1/1012 (0.10%) 
Basal cell carcinoma  1  10/1014 (0.99%)  4/1012 (0.40%) 
Benign gastrointestinal neoplasm  1  0/1014 (0.00%)  1/1012 (0.10%) 
Benign neoplasm of thyroid gland  1  1/1014 (0.10%)  0/1012 (0.00%) 
Benign pancreatic neoplasm  1  0/1014 (0.00%)  1/1012 (0.10%) 
Bladder cancer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Bowen's disease  1  1/1014 (0.10%)  0/1012 (0.00%) 
Brain neoplasm  1  0/1014 (0.00%)  1/1012 (0.10%) 
Breast cancer  1  0/1014 (0.00%)  3/1012 (0.30%) 
Bronchioloalveolar carcinoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cerebral haemangioma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Clear cell renal cell carcinoma  1  1/1014 (0.10%)  0/1012 (0.00%) 
Epstein-Barr virus associated lymphoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Gastric cancer  1  1/1014 (0.10%)  0/1012 (0.00%) 
Leydig cell tumour of the testis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Lipoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Lung adenocarcinoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Lymphoproliferative disorder  1  0/1014 (0.00%)  1/1012 (0.10%) 
Malignant melanoma  1  4/1014 (0.39%)  1/1012 (0.10%) 
Malignant neoplasm of pleura metastatic  1  1/1014 (0.10%)  0/1012 (0.00%) 
Metastases to bone  1  1/1014 (0.10%)  0/1012 (0.00%) 
Metastases to lymph nodes  1  1/1014 (0.10%)  0/1012 (0.00%) 
Metastases to peritoneum  1  1/1014 (0.10%)  0/1012 (0.00%) 
Metastases to spine  1  0/1014 (0.00%)  1/1012 (0.10%) 
Metastatic squamous cell carcinoma  1  1/1014 (0.10%)  0/1012 (0.00%) 
Monoclonal gammopathy  1  1/1014 (0.10%)  0/1012 (0.00%) 
Neoplasm malignant  1  0/1014 (0.00%)  1/1012 (0.10%) 
Non-small cell lung cancer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Oesophageal adenocarcinoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Papillary tumour of renal pelvis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Plasmacytoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Polycythaemia vera  1  1/1014 (0.10%)  0/1012 (0.00%) 
Post transplant lymphoproliferative disorder  1  0/1014 (0.00%)  2/1012 (0.20%) 
Prostate cancer  1  3/1014 (0.30%)  0/1012 (0.00%) 
Renal cancer  1  2/1014 (0.20%)  1/1012 (0.10%) 
Renal cell carcinoma  1  1/1014 (0.10%)  1/1012 (0.10%) 
Salivary gland cancer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Skin cancer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Squamous cell carcinoma  1  8/1014 (0.79%)  4/1012 (0.40%) 
Squamous cell carcinoma of skin  1  0/1014 (0.00%)  5/1012 (0.49%) 
Testicular neoplasm  1  1/1014 (0.10%)  0/1012 (0.00%) 
Tumour of ampulla of Vater  1  0/1014 (0.00%)  1/1012 (0.10%) 
Uterine leiomyoma  1  1/1014 (0.10%)  0/1012 (0.00%) 
Nervous system disorders     
Ataxia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Autoimmune encephalopathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Brain injury  1  1/1014 (0.10%)  0/1012 (0.00%) 
Brain stem infarction  1  0/1014 (0.00%)  1/1012 (0.10%) 
Central nervous system lesion  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cerebellar stroke  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cerebral haemorrhage  1  1/1014 (0.10%)  1/1012 (0.10%) 
Cerebral infarction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cerebral ischaemia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cerebrovascular accident  1  0/1014 (0.00%)  2/1012 (0.20%) 
Coma  1  1/1014 (0.10%)  0/1012 (0.00%) 
Dizziness  1  2/1014 (0.20%)  3/1012 (0.30%) 
Encephalopathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Headache  1  3/1014 (0.30%)  7/1012 (0.69%) 
Hyponatraemic seizure  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypotonia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ischaemic stroke  1  0/1014 (0.00%)  1/1012 (0.10%) 
Metabolic encephalopathy  1  1/1014 (0.10%)  0/1012 (0.00%) 
Migraine  1  0/1014 (0.00%)  1/1012 (0.10%) 
Myelitis transverse  1  0/1014 (0.00%)  1/1012 (0.10%) 
Neuropathy peripheral  1  0/1014 (0.00%)  1/1012 (0.10%) 
Neurotoxicity  1  1/1014 (0.10%)  2/1012 (0.20%) 
Presyncope  1  1/1014 (0.10%)  0/1012 (0.00%) 
Sciatica  1  1/1014 (0.10%)  0/1012 (0.00%) 
Seizure  1  1/1014 (0.10%)  0/1012 (0.00%) 
Spinal cord compression  1  0/1014 (0.00%)  1/1012 (0.10%) 
Syncope  1  1/1014 (0.10%)  3/1012 (0.30%) 
Transient ischaemic attack  1  0/1014 (0.00%)  1/1012 (0.10%) 
Transverse sinus thrombosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Tremor  1  2/1014 (0.20%)  1/1012 (0.10%) 
Visual field defect  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Cephalhaematoma  1  0/1014 (0.00%)  1/1012 (0.10%) 
Product Issues     
Device dislocation  1  2/1014 (0.20%)  1/1012 (0.10%) 
Device leakage  1  0/1014 (0.00%)  1/1012 (0.10%) 
Device malfunction  1  0/1014 (0.00%)  1/1012 (0.10%) 
Psychiatric disorders     
Acute psychosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Aggression  1  0/1014 (0.00%)  1/1012 (0.10%) 
Anxiety  1  1/1014 (0.10%)  0/1012 (0.00%) 
Depression  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hallucination, visual  1  0/1014 (0.00%)  1/1012 (0.10%) 
Mental disorder  1  0/1014 (0.00%)  1/1012 (0.10%) 
Mental status changes  1  1/1014 (0.10%)  2/1012 (0.20%) 
Post-traumatic stress disorder  1  0/1014 (0.00%)  1/1012 (0.10%) 
Psychotic disorder  1  0/1014 (0.00%)  1/1012 (0.10%) 
Suicide attempt  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal and urinary disorders     
Acute kidney injury  1  46/1014 (4.54%)  37/1012 (3.66%) 
Anuria  1  1/1014 (0.10%)  1/1012 (0.10%) 
Bladder neck obstruction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Bladder obstruction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Bladder perforation  1  0/1014 (0.00%)  1/1012 (0.10%) 
Calculus urinary  1  0/1014 (0.00%)  2/1012 (0.20%) 
Chronic kidney disease  1  1/1014 (0.10%)  0/1012 (0.00%) 
Cystitis haemorrhagic  1  1/1014 (0.10%)  0/1012 (0.00%) 
Diabetic nephropathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Dysuria  1  1/1014 (0.10%)  5/1012 (0.49%) 
End stage renal disease  1  1/1014 (0.10%)  0/1012 (0.00%) 
Focal segmental glomerulosclerosis  1  1/1014 (0.10%)  3/1012 (0.30%) 
Glomerulonephritis  1  1/1014 (0.10%)  2/1012 (0.20%) 
Glomerulonephritis chronic  1  1/1014 (0.10%)  0/1012 (0.00%) 
Glomerulonephritis membranoproliferative  1  1/1014 (0.10%)  1/1012 (0.10%) 
Glomerulonephritis membranous  1  1/1014 (0.10%)  1/1012 (0.10%) 
Glycosuria  1  0/1014 (0.00%)  1/1012 (0.10%) 
Haematuria  1  9/1014 (0.89%)  14/1012 (1.38%) 
Haemorrhage urinary tract  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hydronephrosis  1  9/1014 (0.89%)  6/1012 (0.59%) 
Hydroureter  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypertonic bladder  1  0/1014 (0.00%)  1/1012 (0.10%) 
IgM nephropathy  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ischaemic nephropathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Leukocyturia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Mesangioproliferative glomerulonephritis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Nephritis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Nephrolithiasis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Nephropathy  1  0/1014 (0.00%)  1/1012 (0.10%) 
Nephropathy toxic  1  1/1014 (0.10%)  0/1012 (0.00%) 
Nephrotic syndrome  1  0/1014 (0.00%)  1/1012 (0.10%) 
Obstructive nephropathy  1  1/1014 (0.10%)  1/1012 (0.10%) 
Oliguria  1  2/1014 (0.20%)  0/1012 (0.00%) 
Pelvi-ureteric obstruction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Perinephric collection  1  2/1014 (0.20%)  5/1012 (0.49%) 
Pollakiuria  1  2/1014 (0.20%)  0/1012 (0.00%) 
Prerenal failure  1  0/1014 (0.00%)  1/1012 (0.10%) 
Proteinuria  1  15/1014 (1.48%)  3/1012 (0.30%) 
Pyelocaliectasis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Renal artery dissection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Renal artery occlusion  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal artery stenosis  1  4/1014 (0.39%)  7/1012 (0.69%) 
Renal artery thrombosis  1  1/1014 (0.10%)  2/1012 (0.20%) 
Renal cortical necrosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Renal cyst  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal cyst haemorrhage  1  2/1014 (0.20%)  1/1012 (0.10%) 
Renal cyst ruptured  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal failure  1  1/1014 (0.10%)  3/1012 (0.30%) 
Renal haematoma  1  1/1014 (0.10%)  1/1012 (0.10%) 
Renal impairment  1  23/1014 (2.27%)  25/1012 (2.47%) 
Renal ischaemia  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal necrosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Renal tubular atrophy  1  1/1014 (0.10%)  1/1012 (0.10%) 
Renal tubular necrosis  1  3/1014 (0.30%)  5/1012 (0.49%) 
Renal vein thrombosis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Tubulointerstitial nephritis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Ureteric dilatation  1  1/1014 (0.10%)  1/1012 (0.10%) 
Ureteric obstruction  1  3/1014 (0.30%)  1/1012 (0.10%) 
Ureteric stenosis  1  3/1014 (0.30%)  6/1012 (0.59%) 
Urethral obstruction  1  1/1014 (0.10%)  1/1012 (0.10%) 
Urethral stenosis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Urge incontinence  1  0/1014 (0.00%)  1/1012 (0.10%) 
Urinary bladder haemorrhage  1  1/1014 (0.10%)  0/1012 (0.00%) 
Urinary bladder polyp  1  0/1014 (0.00%)  1/1012 (0.10%) 
Urinary fistula  1  3/1014 (0.30%)  2/1012 (0.20%) 
Urinary incontinence  1  9/1014 (0.89%)  1/1012 (0.10%) 
Urinary retention  1  1/1014 (0.10%)  8/1012 (0.79%) 
Urinary tract obstruction  1  2/1014 (0.20%)  4/1012 (0.40%) 
Urinoma  1  1/1014 (0.10%)  0/1012 (0.00%) 
Vesicoureteric reflux  1  1/1014 (0.10%)  0/1012 (0.00%) 
Reproductive system and breast disorders     
Acquired hydrocele  1  0/1014 (0.00%)  1/1012 (0.10%) 
Benign prostatic hyperplasia  1  2/1014 (0.20%)  3/1012 (0.30%) 
Cervical dysplasia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Endometriosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Erectile dysfunction  1  1/1014 (0.10%)  0/1012 (0.00%) 
Menorrhagia  1  1/1014 (0.10%)  0/1012 (0.00%) 
Ovarian cyst ruptured  1  1/1014 (0.10%)  0/1012 (0.00%) 
Prostatitis  1  3/1014 (0.30%)  4/1012 (0.40%) 
Scrotal oedema  1  1/1014 (0.10%)  0/1012 (0.00%) 
Testicular oedema  1  1/1014 (0.10%)  0/1012 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  2/1014 (0.20%)  2/1012 (0.20%) 
Acute respiratory failure  1  2/1014 (0.20%)  4/1012 (0.40%) 
Asthma  1  1/1014 (0.10%)  1/1012 (0.10%) 
Asthmatic crisis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Bronchospasm  1  0/1014 (0.00%)  1/1012 (0.10%) 
Cough  1  0/1014 (0.00%)  2/1012 (0.20%) 
Dyspnoea  1  8/1014 (0.79%)  7/1012 (0.69%) 
Dyspnoea exertional  1  1/1014 (0.10%)  1/1012 (0.10%) 
Epistaxis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Haemoptysis  1  2/1014 (0.20%)  2/1012 (0.20%) 
Hyperventilation  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypoxia  1  1/1014 (0.10%)  2/1012 (0.20%) 
Interstitial lung disease  1  1/1014 (0.10%)  0/1012 (0.00%) 
Lung disorder  1  2/1014 (0.20%)  0/1012 (0.00%) 
Lung infiltration  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pleural effusion  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pleurisy  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pleuritic pain  1  1/1014 (0.10%)  2/1012 (0.20%) 
Pneumonia aspiration  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pneumonitis  1  4/1014 (0.39%)  0/1012 (0.00%) 
Productive cough  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pulmonary artery thrombosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pulmonary congestion  1  1/1014 (0.10%)  0/1012 (0.00%) 
Pulmonary embolism  1  17/1014 (1.68%)  6/1012 (0.59%) 
Pulmonary hypertension  1  1/1014 (0.10%)  2/1012 (0.20%) 
Pulmonary mass  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pulmonary oedema  1  3/1014 (0.30%)  2/1012 (0.20%) 
Respiratory failure  1  3/1014 (0.30%)  4/1012 (0.40%) 
Skin and subcutaneous tissue disorders     
Blister  1  0/1014 (0.00%)  1/1012 (0.10%) 
Capillaritis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Dermatitis allergic  1  0/1014 (0.00%)  1/1012 (0.10%) 
Diabetic foot  1  0/1014 (0.00%)  1/1012 (0.10%) 
Erythema  1  0/1014 (0.00%)  1/1012 (0.10%) 
Hyperhidrosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Neuropathic ulcer  1  0/1014 (0.00%)  1/1012 (0.10%) 
Peau d'orange  1  1/1014 (0.10%)  0/1012 (0.00%) 
Skin necrosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Skin oedema  1  1/1014 (0.10%)  0/1012 (0.00%) 
Skin ulcer  1  1/1014 (0.10%)  1/1012 (0.10%) 
Urticaria  1  1/1014 (0.10%)  1/1012 (0.10%) 
Social circumstances     
Loss of personal independence in daily activities  1  1/1014 (0.10%)  0/1012 (0.00%) 
Walking disability  1  1/1014 (0.10%)  0/1012 (0.00%) 
Surgical and medical procedures     
Arteriovenous fistula operation  1  0/1014 (0.00%)  1/1012 (0.10%) 
Orchidectomy  1  1/1014 (0.10%)  0/1012 (0.00%) 
Vascular disorders     
Accelerated hypertension  1  1/1014 (0.10%)  0/1012 (0.00%) 
Aortic aneurysm  1  1/1014 (0.10%)  0/1012 (0.00%) 
Aortic perforation  1  0/1014 (0.00%)  1/1012 (0.10%) 
Arterial stenosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Arterial thrombosis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Arteriovenous fistula  1  1/1014 (0.10%)  1/1012 (0.10%) 
Artery dissection  1  1/1014 (0.10%)  0/1012 (0.00%) 
Deep vein thrombosis  1  20/1014 (1.97%)  12/1012 (1.19%) 
Embolism venous  1  1/1014 (0.10%)  0/1012 (0.00%) 
Haematoma  1  1/1014 (0.10%)  3/1012 (0.30%) 
Hypertension  1  2/1014 (0.20%)  6/1012 (0.59%) 
Hypertensive crisis  1  3/1014 (0.30%)  5/1012 (0.49%) 
Hypertensive emergency  1  1/1014 (0.10%)  0/1012 (0.00%) 
Hypotension  1  3/1014 (0.30%)  8/1012 (0.79%) 
Intermittent claudication  1  0/1014 (0.00%)  1/1012 (0.10%) 
Lymphocele  1  34/1014 (3.35%)  21/1012 (2.08%) 
Lymphorrhoea  1  3/1014 (0.30%)  0/1012 (0.00%) 
Malignant hypertension  1  1/1014 (0.10%)  0/1012 (0.00%) 
Orthostatic hypotension  1  0/1014 (0.00%)  1/1012 (0.10%) 
Pelvic venous thrombosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Peripheral arterial occlusive disease  1  1/1014 (0.10%)  1/1012 (0.10%) 
Peripheral artery stenosis  1  0/1014 (0.00%)  2/1012 (0.20%) 
Peripheral artery thrombosis  1  2/1014 (0.20%)  1/1012 (0.10%) 
Peripheral ischaemia  1  2/1014 (0.20%)  1/1012 (0.10%) 
Phlebitis  1  1/1014 (0.10%)  0/1012 (0.00%) 
Shock haemorrhagic  1  1/1014 (0.10%)  2/1012 (0.20%) 
Thrombophlebitis superficial  1  0/1014 (0.00%)  1/1012 (0.10%) 
Thrombosis  1  2/1014 (0.20%)  0/1012 (0.00%) 
Varicose ulceration  1  1/1014 (0.10%)  0/1012 (0.00%) 
Venous stenosis  1  0/1014 (0.00%)  1/1012 (0.10%) 
Venous thrombosis  1  1/1014 (0.10%)  3/1012 (0.30%) 
Venous thrombosis limb  1  0/1014 (0.00%)  1/1012 (0.10%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus Plus@Reduced CNI MPA Plus Standard@CNI
Affected / at Risk (%) Affected / at Risk (%)
Total   951/1014 (93.79%)   942/1012 (93.08%) 
Blood and lymphatic system disorders     
Anaemia  1  227/1014 (22.39%)  238/1012 (23.52%) 
Leukocytosis  1  24/1014 (2.37%)  58/1012 (5.73%) 
Leukopenia  1  94/1014 (9.27%)  194/1012 (19.17%) 
Polycythaemia  1  52/1014 (5.13%)  42/1012 (4.15%) 
Thrombocytopenia  1  74/1014 (7.30%)  41/1012 (4.05%) 
Cardiac disorders     
Tachycardia  1  53/1014 (5.23%)  52/1012 (5.14%) 
Gastrointestinal disorders     
Abdominal pain  1  94/1014 (9.27%)  104/1012 (10.28%) 
Abdominal pain upper  1  39/1014 (3.85%)  62/1012 (6.13%) 
Constipation  1  245/1014 (24.16%)  242/1012 (23.91%) 
Diarrhoea  1  242/1014 (23.87%)  318/1012 (31.42%) 
Nausea  1  191/1014 (18.84%)  225/1012 (22.23%) 
Vomiting  1  120/1014 (11.83%)  140/1012 (13.83%) 
General disorders     
Fatigue  1  59/1014 (5.82%)  64/1012 (6.32%) 
Oedema peripheral  1  347/1014 (34.22%)  244/1012 (24.11%) 
Pyrexia  1  112/1014 (11.05%)  132/1012 (13.04%) 
Infections and infestations     
BK virus infection  1  56/1014 (5.52%)  101/1012 (9.98%) 
Cytomegalovirus infection  1  24/1014 (2.37%)  93/1012 (9.19%) 
Nasopharyngitis  1  110/1014 (10.85%)  117/1012 (11.56%) 
Upper respiratory tract infection  1  81/1014 (7.99%)  102/1012 (10.08%) 
Urinary tract infection  1  219/1014 (21.60%)  249/1012 (24.60%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  63/1014 (6.21%)  54/1012 (5.34%) 
Incision site pain  1  51/1014 (5.03%)  61/1012 (6.03%) 
Procedural pain  1  90/1014 (8.88%)  99/1012 (9.78%) 
Investigations     
Blood creatinine increased  1  141/1014 (13.91%)  133/1012 (13.14%) 
Weight increased  1  38/1014 (3.75%)  66/1012 (6.52%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  133/1014 (13.12%)  120/1012 (11.86%) 
Dyslipidaemia  1  98/1014 (9.66%)  57/1012 (5.63%) 
Hypercalcaemia  1  39/1014 (3.85%)  67/1012 (6.62%) 
Hypercholesterolaemia  1  103/1014 (10.16%)  61/1012 (6.03%) 
Hyperglycaemia  1  140/1014 (13.81%)  144/1012 (14.23%) 
Hyperkalaemia  1  164/1014 (16.17%)  184/1012 (18.18%) 
Hyperlipidaemia  1  135/1014 (13.31%)  75/1012 (7.41%) 
Hypertriglyceridaemia  1  58/1014 (5.72%)  24/1012 (2.37%) 
Hyperuricaemia  1  49/1014 (4.83%)  64/1012 (6.32%) 
Hypocalcaemia  1  109/1014 (10.75%)  98/1012 (9.68%) 
Hypokalaemia  1  148/1014 (14.60%)  87/1012 (8.60%) 
Hypomagnesaemia  1  134/1014 (13.21%)  168/1012 (16.60%) 
Hypophosphataemia  1  190/1014 (18.74%)  167/1012 (16.50%) 
Metabolic acidosis  1  77/1014 (7.59%)  98/1012 (9.68%) 
Vitamin D deficiency  1  53/1014 (5.23%)  57/1012 (5.63%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  63/1014 (6.21%)  65/1012 (6.42%) 
Back pain  1  93/1014 (9.17%)  98/1012 (9.68%) 
Pain in extremity  1  66/1014 (6.51%)  61/1012 (6.03%) 
Nervous system disorders     
Dizziness  1  51/1014 (5.03%)  54/1012 (5.34%) 
Headache  1  133/1014 (13.12%)  113/1012 (11.17%) 
Tremor  1  100/1014 (9.86%)  145/1012 (14.33%) 
Psychiatric disorders     
Anxiety  1  51/1014 (5.03%)  59/1012 (5.83%) 
Insomnia  1  100/1014 (9.86%)  138/1012 (13.64%) 
Renal and urinary disorders     
Dysuria  1  60/1014 (5.92%)  74/1012 (7.31%) 
Haematuria  1  102/1014 (10.06%)  101/1012 (9.98%) 
Proteinuria  1  131/1014 (12.92%)  69/1012 (6.82%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  86/1014 (8.48%)  102/1012 (10.08%) 
Dyspnoea  1  73/1014 (7.20%)  70/1012 (6.92%) 
Skin and subcutaneous tissue disorders     
Acne  1  56/1014 (5.52%)  37/1012 (3.66%) 
Alopecia  1  27/1014 (2.66%)  59/1012 (5.83%) 
Vascular disorders     
Hypertension  1  240/1014 (23.67%)  230/1012 (22.73%) 
Hypotension  1  62/1014 (6.11%)  78/1012 (7.71%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharma
Phone: 8627788300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01950819     History of Changes
Obsolete Identifiers: NCT02316938
Other Study ID Numbers: CRAD001A2433
2013-000322-66 ( EudraCT Number )
First Submitted: August 20, 2013
First Posted: September 26, 2013
Results First Submitted: October 3, 2018
Results First Posted: January 30, 2019
Last Update Posted: January 30, 2019