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12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients (ATHENA)

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: NCT01843348
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : May 1, 2017
Last Update Posted : May 1, 2017
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 Kidney Transplantation
Renal Transplantation
Interventions Drug: Everolimus
Drug: Tacrolimus
Drug: Cyclosporin A
Drug: Enteric Coated Mycophenolate Sodium (EC-MPS)
Drug: Mycophenolate mofetil (MMF)
Drug: Corticosteroids
Drug: Simulect
Enrollment 612
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect Tacrolimus, Certican, corticosteroids and Simulect Cyclosporin A, Certican, corticosteroids and Simulect
Period Title: Overall Study
Started 205 208 199
Safety Analysis Set (SAS) 204 [1] 210 [2] 198 [1]
Full Analysis Set (FAS) 205 [3] 208 [3] 199 [3]
Per Protocol Set (PPS) 147 [4] 111 [4] 80 [4]
Completed 182 168 158
Not Completed 23 40 41
Reason Not Completed
Withdrawal by Subject             4             16             18
Lost to Follow-up             5             4             2
Death             5             3             4
Graft loss/retransplantation             5             8             11
Various reasons             4             9             6
[1]
One participant received TAC + Certican in error - analyzed with TAC + Certican arm
[2]
Two participants received TAC + Certican in other arms in errorr - analyzed with TAC + Certican arm
[3]
Participants in the FAS received at least one dose of study drug
[4]
Participants in the FAS without major protocol deviations
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican Total
Hide Arm/Group Description Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect Tacrolimus, Certican, corticosteroids and Simulect Cyclosporin A, Certican, corticosteroids and Simulect Total of all reporting groups
Overall Number of Baseline Participants 205 208 199 612
Hide Baseline Analysis Population Description
Full analysis set consisted of all randomized patients who received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 205 participants 208 participants 199 participants 612 participants
55.3  (12.09) 54.3  (13.50) 55.1  (12.61) 54.9  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 208 participants 199 participants 612 participants
Female
65
  31.7%
70
  33.7%
66
  33.2%
201
  32.8%
Male
140
  68.3%
138
  66.3%
133
  66.8%
411
  67.2%
1.Primary Outcome
Title Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
Hide Description

To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula:

GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set
Time Frame One year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol analysis set comprised of participants who received at least one dose of study drug without major protocol deviaitons
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 147 111 80
Mean (Standard Deviation)
Unit of Measure: mL/min per 1.73m²
Month 1 - Day 1 to 60 (146,111,78) 62.62  (16.931) 60.54  (17.310) 59.47  (16.754)
Month 3 - Day 61 to 136 (143,108,79) 66.36  (16.672) 61.21  (14.771) 62.22  (16.196)
Month 6 - Day 137 to 228 (142,108,76) 68.05  (16.994) 62.76  (16.763) 63.17  (16.789)
Month 9 - Day 229 to 319 (140,106,77) 69.47  (16.251) 64.68  (15.507) 62.89  (14.947)
Month12 - Day 320 to 450 (147,111, 80) 70.41  (16.514) 63.34  (16.986) 61.51  (16.942)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAC+MPA, CycA+Certican
Comments The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean
Estimated Value -9.35
Confidence Interval (2-Sided) 95%
-13.82 to -4.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAC+MPA, TAC+Certican
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin
Statistical Test of Hypothesis P-Value 0.0067
Comments Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -5.56
Confidence Interval (2-Sided) 95%
-9.56 to -1.55
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12
Hide Description Combined endpoint included: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)
Time Frame Month 12 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set includes all participants who received at least one dose of study drug.
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican Tac+Certican - Tac+MPA - Difference Between Groups CycA+Certican -Tac+MPA - Difference Between Groups
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 205 208 199 413 404
Measure Type: Number
Unit of Measure: Percentage of participants
BPAR or graft loss or death 9.8 13.0 24.6 3.2 14.9
BPAR, graft loss, death, or loss of follow-up 15.6 22.6 32.7 7.0 17.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAC+MPA, TAC+Certican
Comments TAC+Certican - TAC+MPA - difference between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate
Estimated Value 0.032
Confidence Interval (2-Sided) 95%
-0.029 to 0.093
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAC+MPA, CycA+Certican
Comments CycA+Certican -Tac+MPA - difference between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate
Estimated Value 0.149
Confidence Interval (2-Sided) 95%
0.076 to 0.221
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant
Hide Description Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method = GFR=141 x min(Scr/κ, 1)α x max(Scr/κ, 1)1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black] where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is 0.329 for females and 0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Time Frame Month 12 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 181 166 158
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/min per 1.73m²
51.62
(48.10 to 55.14)
44.42
(40.95 to 47.89)
42.44
(38.89 to 45.99)
4.Secondary Outcome
Title Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant
Hide Description Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Time Frame Month 12 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 174 162 151
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/min per 1.73m²
60.26
(55.85 to 64.68)
52.25
(47.88 to 56.61)
51.30
(46.85 to 55.74)
5.Secondary Outcome
Title Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant
Hide Description Modification of Diet in Renal Disease (MDRD) = For men: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x (albumin0,318) For women: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x albumin0,318) x 0.762 with urea nitrogen = urea / 2.144. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Time Frame Month 12 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 172 156 140
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/min per 1.73m²
53.24
(49.62 to 56.87)
45.72
(42.11 to 49.32)
43.47
(39.75 to 47.20)
6.Secondary Outcome
Title Percentage of Participants With Treatment Failure Endpoints at Month 12
Hide Description Treatment failure endpoints: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)
Time Frame Month 12 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 205 208 199
Measure Type: Number
Unit of Measure: Percentage of participants
Biopsy proven acute rejection (BPAR) 9.3 12.0 24.6
Treated BPAR (tBPAR) 8.8 11.5 23.6
Graft loss 5.4 6.3 9.0
Death 4.9 6.3 6.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAC+MPA, TAC+Certican
Comments BPAR - treatment differences at Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Pearson's chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 0.028
Confidence Interval (2-Sided) 95%
-0.032 to 0.087
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent of Participants With Delayed Graft Function and Slow Graft Function
Hide Description Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function (SGF) was defined as a serum creatinine >3.0 mg/dL at Day 5 post-transplantation. Full analysis set
Time Frame Post transplant to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 205 208 199
Measure Type: Number
Unit of Measure: Percent of participants
Delayed graft function (197,187,172) 17.8 20.3 22.1
Slow graft function (195,187,171) 46.2 48.7 49.7
8.Secondary Outcome
Title Percent of Participants With Delayed Graft Function by Day
Hide Description Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.
Time Frame Post transplant up to day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 35 38 38
Measure Type: Number
Unit of Measure: Percent of participants
day 1 (8,7,4) 22.9 18.4 10.5
day 2 (2,2,2) 5.7 5.3 5.3
day 3 (5,1,2) 14.3 2.6 5.3
day 4 (4,2,4) 11.4 5.3 10.5
day 5 (4,5,3) 11.4 13.2 7.9
day 6 (1,1,2) 2.9 2.6 5.3
day 7 (2,4,0) 5.7 10.5 0.0
>7 days (9,16,21) 25.7 42.1 55.3
9.Secondary Outcome
Title Percent of Participants With Viral Infections
Hide Description Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus
Time Frame Post transplant to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 204 210 198
Measure Type: Number
Unit of Measure: Percent of participants
Viral infections - CMVMissing 1.0 0.0 1.0
Viral infections - CMVAsymptomatic 7.0 1.0 1.0
Viral infections - CMVMild 5.0 2.0 1.0
Viral infections - CMVModerate 6.0 1.0 1.0
Viral infections - CMVSevere 1.0 0.0 0.0
Viral infections - BKVAsymptomatic 10.0 8.0 5.0
Viral infections - BKVMild 5.0 7.0 3.0
Viral infections - BKVModerate 7.0 2.0 1.0
Viral infections - BKVSevere 0 0 0
10.Secondary Outcome
Title Percent of Participants With Wound Healing Complications During Study
Hide Description Information collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles
Time Frame Post transplant until individual reporting
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 204 210 198
Measure Type: Number
Unit of Measure: Percent of participants
Wound healing complication 14.3 19.1 22.2
Fluids detected 18.7 26.8 27.8
Occurrence of lymphoceles 11.8 18.2 21.8
11.Secondary Outcome
Title Duration of Wound Healing
Hide Description A wound will be considered healed if all the suture material and staples are removed and the wound is intact. Number of participants is based on all patients of the respective treatment group in the safety set, excluding patients with no answer (unknown).
Time Frame Post transplant until individual reporting
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAC+MPA TAC+Certican CycA+Certican
Hide Arm/Group Description:
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
Tacrolimus, Certican, corticosteroids and Simulect
Cyclosporin A, Certican, corticosteroids and Simulect
Overall Number of Participants Analyzed 28 34 38
Mean (Standard Deviation)
Unit of Measure: days
42.4  (41.13) 54.1  (61.97) 85.3  (62.7)
Time Frame Timeframe for AE
Adverse Event Reporting Description AE additional description
 
Arm/Group Title Tac+MPA Tac+Certican CycA+Certican
Hide Arm/Group Description Tac+MPA Tac+Certican CycA+Certican
All-Cause Mortality
Tac+MPA Tac+Certican CycA+Certican
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Tac+MPA Tac+Certican CycA+Certican
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   135/204 (66.18%)   161/210 (76.67%)   144/198 (72.73%) 
Blood and lymphatic system disorders       
Anaemia † 1  1/204 (0.49%)  3/210 (1.43%)  4/198 (2.02%) 
Febrile neutropenia † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Haemolytic uraemic syndrome † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Histiocytosis haematophagic † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Leukopenia † 1  5/204 (2.45%)  1/210 (0.48%)  2/198 (1.01%) 
Lymphadenopathy † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Lymphatic disorder † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Nephrogenic anaemia † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Neutropenia † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Pancytopenia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Splenic lesion † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Thrombocytopenia † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Cardiac disorders       
Acute coronary syndrome † 1  0/204 (0.00%)  1/210 (0.48%)  2/198 (1.01%) 
Acute myocardial infarction † 1  2/204 (0.98%)  2/210 (0.95%)  3/198 (1.52%) 
Angina pectoris † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Angina unstable † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Atrial fibrillation † 1  4/204 (1.96%)  1/210 (0.48%)  1/198 (0.51%) 
Atrioventricular block second degree † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Bradyarrhythmia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Bradycardia † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Cardiac failure † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Cardiac flutter † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Cardiogenic shock † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Cardiomyopathy † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Cardiovascular disorder † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Coronary artery disease † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Intracardiac thrombus † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Long QT syndrome † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Mitral valve disease † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Myocardial infarction † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Myocardial ischaemia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Congenital, familial and genetic disorders       
Abdominal wall anomaly † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Congenital cystic kidney disease † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Hydrocele † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Ear and labyrinth disorders       
Sudden hearing loss † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Vertigo † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Endocrine disorders       
Hyperparathyroidism † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Parathyroid gland enlargement † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Eye disorders       
Eyelid oedema † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Retinal detachment † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Gastrointestinal disorders       
Abdominal distension † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Abdominal hernia † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Abdominal pain † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Abdominal pain upper † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Abdominal wall haematoma † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Anal sphincter atony † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Colitis microscopic † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Constipation † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Diverticular perforation † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Dysphagia † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Gastritis † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Gastrointestinal haemorrhage † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Haemorrhoidal haemorrhage † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Haemorrhoids † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Hernial eventration † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Hiatus hernia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Ileus † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Inguinal hernia † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Intestinal ischaemia † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Intestinal obstruction † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Intra-abdominal haematoma † 1  1/204 (0.49%)  1/210 (0.48%)  1/198 (0.51%) 
Large intestine perforation † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Localised intraabdominal fluid collection † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Lower gastrointestinal haemorrhage † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Nausea † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Oesophageal ulcer † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Pancreatitis acute † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Peritoneal haemorrhage † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Pneumoperitoneum † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Rectal haemorrhage † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Retroperitoneal haematoma † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Retroperitoneal haemorrhage † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Stomatitis † 1  0/204 (0.00%)  0/210 (0.00%)  2/198 (1.01%) 
Volvulus † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
General disorders       
Asthenia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Drug intolerance † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
General physical health deterioration † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Hyperthermia † 1  1/204 (0.49%)  1/210 (0.48%)  1/198 (0.51%) 
Impaired healing † 1  2/204 (0.98%)  5/210 (2.38%)  4/198 (2.02%) 
Incarcerated hernia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Inflammation † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Malaise † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Multiple organ dysfunction syndrome † 1  0/204 (0.00%)  0/210 (0.00%)  3/198 (1.52%) 
Oedema † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Oedema peripheral † 1  0/204 (0.00%)  4/210 (1.90%)  2/198 (1.01%) 
Pain † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Peripheral swelling † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Pyrexia † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Hydrocholecystis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Portal vein thrombosis † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Immune system disorders       
Anaphylactic reaction † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Chronic allograft nephropathy † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Hypersensitivity † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Kidney transplant rejection † 1  8/204 (3.92%)  19/210 (9.05%)  22/198 (11.11%) 
Renal transplant failure † 1  8/204 (3.92%)  9/210 (4.29%)  11/198 (5.56%) 
Transplant rejection † 1  8/204 (3.92%)  5/210 (2.38%)  17/198 (8.59%) 
Infections and infestations       
Abdominal abscess † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Aspergillus infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Atypical pneumonia † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
BK virus infection † 1  3/204 (1.47%)  3/210 (1.43%)  1/198 (0.51%) 
Bacteraemia † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Bacterial pyelonephritis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Bronchitis † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Clostridium difficile colitis † 1  2/204 (0.98%)  1/210 (0.48%)  2/198 (1.01%) 
Clostridium difficile infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Corona virus infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Cryptosporidiosis infection † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Cytomegalovirus colitis † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Cytomegalovirus infection † 1  11/204 (5.39%)  2/210 (0.95%)  2/198 (1.01%) 
Device related infection † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Diarrhoea infectious † 1  4/204 (1.96%)  6/210 (2.86%)  6/198 (3.03%) 
Diverticulitis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Enterococcal infection † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Enterocolitis viral † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Epididymitis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Epstein-Barr virus infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Erysipelas † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Escherichia infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Escherichia sepsis † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Febrile infection † 1  2/204 (0.98%)  1/210 (0.48%)  2/198 (1.01%) 
Gastroenteritis † 1  2/204 (0.98%)  5/210 (2.38%)  3/198 (1.52%) 
Gastroenteritis norovirus † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Graft infection † 1  1/204 (0.49%)  4/210 (1.90%)  1/198 (0.51%) 
Haemophilus infection † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Herpes simplex † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Herpes zoster † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Infected lymphocele † 1  1/204 (0.49%)  2/210 (0.95%)  3/198 (1.52%) 
Infection † 1  2/204 (0.98%)  5/210 (2.38%)  5/198 (2.53%) 
Influenza † 1  0/204 (0.00%)  3/210 (1.43%)  0/198 (0.00%) 
Kidney infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Klebsiella infection † 1  0/204 (0.00%)  0/210 (0.00%)  2/198 (1.01%) 
Localised infection † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Lung infection † 1  2/204 (0.98%)  3/210 (1.43%)  1/198 (0.51%) 
Mastitis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Myocarditis infectious † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Orchitis † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Peritonitis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Pharyngitis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Pneumocystis jirovecii pneumonia † 1  1/204 (0.49%)  1/210 (0.48%)  1/198 (0.51%) 
Pneumonia † 1  4/204 (1.96%)  10/210 (4.76%)  8/198 (4.04%) 
Pneumonia bacterial † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Pneumonia fungal † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Pneumonia legionella † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Polyomavirus-associated nephropathy † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Pulmonary sepsis † 1  0/204 (0.00%)  0/210 (0.00%)  2/198 (1.01%) 
Pyelonephritis † 1  10/204 (4.90%)  9/210 (4.29%)  8/198 (4.04%) 
Pyelonephritis acute † 1  0/204 (0.00%)  5/210 (2.38%)  1/198 (0.51%) 
Renal abscess † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Renal cyst infection † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Respiratory tract infection † 1  1/204 (0.49%)  1/210 (0.48%)  1/198 (0.51%) 
Rotavirus infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Sepsis † 1  0/204 (0.00%)  5/210 (2.38%)  1/198 (0.51%) 
Septic shock † 1  2/204 (0.98%)  1/210 (0.48%)  0/198 (0.00%) 
Shunt infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Sinusitis † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Skin infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Subcutaneous abscess † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Upper respiratory tract infection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Ureteritis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Urinary tract infection † 1  21/204 (10.29%)  27/210 (12.86%)  16/198 (8.08%) 
Urosepsis † 1  9/204 (4.41%)  6/210 (2.86%)  7/198 (3.54%) 
Varicella zoster virus infection † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Wound infection † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Injury, poisoning and procedural complications       
Abdominal wound dehiscence † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Anastomotic complication † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Ankle fracture † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Arterial injury † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Arteriovenous fistula site complication † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Arteriovenous fistula thrombosis † 1  1/204 (0.49%)  1/210 (0.48%)  1/198 (0.51%) 
Complications of transplanted kidney † 1  18/204 (8.82%)  22/210 (10.48%)  18/198 (9.09%) 
Fall † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Femoral neck fracture † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Femur fracture † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Graft complication † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Graft haemorrhage † 1  0/204 (0.00%)  2/210 (0.95%)  4/198 (2.02%) 
Graft thrombosis † 1  1/204 (0.49%)  2/210 (0.95%)  2/198 (1.01%) 
Hand fracture † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Incisional hernia † 1  0/204 (0.00%)  1/210 (0.48%)  3/198 (1.52%) 
Injury † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Kidney rupture † 1  0/204 (0.00%)  1/210 (0.48%)  2/198 (1.01%) 
Perinephric collection † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Perirenal haematoma † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Post procedural haematoma † 1  1/204 (0.49%)  0/210 (0.00%)  3/198 (1.52%) 
Post procedural haematuria † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Post procedural haemorrhage † 1  0/204 (0.00%)  2/210 (0.95%)  4/198 (2.02%) 
Post procedural urine leak † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Radius fracture † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Seroma † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Shunt aneurysm † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Shunt blood flow excessive † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Shunt occlusion † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Shunt thrombosis † 1  3/204 (1.47%)  3/210 (1.43%)  0/198 (0.00%) 
Spinal compression fracture † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Toxicity to various agents † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Transplant dysfunction † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Traumatic haematoma † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Traumatic haemothorax † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Ureteric anastomosis complication † 1  1/204 (0.49%)  2/210 (0.95%)  0/198 (0.00%) 
Vascular graft stenosis † 1  2/204 (0.98%)  0/210 (0.00%)  0/198 (0.00%) 
Wound dehiscence † 1  3/204 (1.47%)  3/210 (1.43%)  4/198 (2.02%) 
Wound necrosis † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Investigations       
Anticoagulation drug level below therapeutic † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Blood creatine increased † 1  0/204 (0.00%)  2/210 (0.95%)  1/198 (0.51%) 
Blood creatinine decreased † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Blood creatinine increased † 1  11/204 (5.39%)  20/210 (9.52%)  19/198 (9.60%) 
C-reactive protein increased † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Cardiac monitoring † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Creatinine renal clearance decreased † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Epstein-Barr virus antigen positive † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
General physical condition abnormal † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Haemoglobin decreased † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Hepatic enzyme increased † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Weight decreased † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Metabolism and nutrition disorders       
Acidosis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Decreased appetite † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Dehydration † 1  2/204 (0.98%)  3/210 (1.43%)  3/198 (1.52%) 
Diabetes mellitus † 1  3/204 (1.47%)  5/210 (2.38%)  4/198 (2.02%) 
Diabetes mellitus inadequate control † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Diabetic ketoacidosis † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Hypercalcaemia † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Hyperglycaemia † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Hyperkalaemia † 1  5/204 (2.45%)  3/210 (1.43%)  1/198 (0.51%) 
Hypocalcaemia † 1  1/204 (0.49%)  2/210 (0.95%)  0/198 (0.00%) 
Hypoglycaemia † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Hyponatraemia † 1  0/204 (0.00%)  3/210 (1.43%)  0/198 (0.00%) 
Hypophosphataemia † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Type 2 diabetes mellitus † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Hypercreatinaemia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Muscle haemorrhage † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Myalgia † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Osteonecrosis † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Spinal osteoarthritis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-cell unclassifiable lymphoma high grade † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Basal cell carcinoma † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Bowen's disease † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Cardiac myxoma † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Cardiac valve fibroelastoma † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Clear cell renal cell carcinoma † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Colon cancer † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Fibroma † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Lung neoplasm malignant † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Malignant melanoma † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Marrow hyperplasia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Mucinous adenocarcinoma of appendix † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Neuroendocrine tumour † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Parathyroid tumour benign † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Prostate cancer † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Rectal neoplasm † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Renal cancer † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Renal cell carcinoma † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Seminoma † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Nervous system disorders       
Balance disorder † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Cerebral ischaemia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Monoparesis † 1  0/204 (0.00%)  0/210 (0.00%)  2/198 (1.01%) 
Neuralgia † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Polyneuropathy † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Post herpetic neuralgia † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Sensory loss † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Transient ischaemic attack † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Product Issues       
Device leakage † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Device occlusion † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Psychiatric disorders       
Affective disorder † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Confusional state † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Depression † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Depressive symptom † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Disorientation † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Mental disorder † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Renal and urinary disorders       
Acute kidney injury † 1  9/204 (4.41%)  12/210 (5.71%)  7/198 (3.54%) 
Bladder pain † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Bladder tamponade † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Dysuria † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Focal segmental glomerulosclerosis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Glomerulonephritis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Hydronephrosis † 1  2/204 (0.98%)  4/210 (1.90%)  0/198 (0.00%) 
Micturition disorder † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Nephrocalcinosis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Obstructive uropathy † 1  0/204 (0.00%)  1/210 (0.48%)  3/198 (1.52%) 
Postrenal failure † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Proteinuria † 1  0/204 (0.00%)  5/210 (2.38%)  1/198 (0.51%) 
Renal artery dissection † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Renal artery stenosis † 1  4/204 (1.96%)  2/210 (0.95%)  2/198 (1.01%) 
Renal cyst † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Renal cyst haemorrhage † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Renal failure † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Renal haematoma † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Renal haemorrhage † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Renal impairment † 1  2/204 (0.98%)  8/210 (3.81%)  4/198 (2.02%) 
Renal infarct † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Renal tubular disorder † 1  1/204 (0.49%)  2/210 (0.95%)  0/198 (0.00%) 
Renal tubular necrosis † 1  0/204 (0.00%)  0/210 (0.00%)  2/198 (1.01%) 
Ureteral necrosis † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Ureteric stenosis † 1  1/204 (0.49%)  2/210 (0.95%)  1/198 (0.51%) 
Urethral stenosis † 1  2/204 (0.98%)  1/210 (0.48%)  0/198 (0.00%) 
Urinary fistula † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Urinary retention † 1  3/204 (1.47%)  1/210 (0.48%)  1/198 (0.51%) 
Urinary tract obstruction † 1  1/204 (0.49%)  5/210 (2.38%)  2/198 (1.01%) 
Urinoma † 1  1/204 (0.49%)  1/210 (0.48%)  2/198 (1.01%) 
Vesicoureteric reflux † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia † 1  3/204 (1.47%)  2/210 (0.95%)  3/198 (1.52%) 
Endometriosis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Ovarian cyst † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Pelvic haematoma † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Prostatitis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
Dyspnoea † 1  1/204 (0.49%)  2/210 (0.95%)  0/198 (0.00%) 
Dyspnoea exertional † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Epistaxis † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Haemoptysis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Haemothorax † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Interstitial lung disease † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Laryngeal cyst † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Lung disorder † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Pleural effusion † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Pneumonitis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Pulmonary congestion † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Pulmonary embolism † 1  4/204 (1.96%)  1/210 (0.48%)  5/198 (2.53%) 
Pulmonary mass † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Pulmonary oedema † 1  1/204 (0.49%)  3/210 (1.43%)  0/198 (0.00%) 
Respiratory failure † 1  0/204 (0.00%)  1/210 (0.48%)  3/198 (1.52%) 
Skin and subcutaneous tissue disorders       
Actinic keratosis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Angioedema † 1  0/204 (0.00%)  2/210 (0.95%)  0/198 (0.00%) 
Rash † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Skin lesion † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Skin ulcer † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Stasis dermatitis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Surgical and medical procedures       
Renal transplant † 1  4/204 (1.96%)  5/210 (2.38%)  5/198 (2.53%) 
Steroid therapy † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Transurethral prostatectomy † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Vascular anastomosis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Vascular disorders       
Arteriosclerosis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Arteriovenous fistula † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Deep vein thrombosis † 1  2/204 (0.98%)  0/210 (0.00%)  3/198 (1.52%) 
Haematoma † 1  5/204 (2.45%)  9/210 (4.29%)  3/198 (1.52%) 
Haemorrhage † 1  0/204 (0.00%)  3/210 (1.43%)  0/198 (0.00%) 
Hypertension † 1  0/204 (0.00%)  2/210 (0.95%)  1/198 (0.51%) 
Hypertensive crisis † 1  3/204 (1.47%)  0/210 (0.00%)  1/198 (0.51%) 
Hypotension † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Lymphocele † 1  12/204 (5.88%)  19/210 (9.05%)  24/198 (12.12%) 
Lymphoedema † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Lymphorrhoea † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Orthostatic hypotension † 1  0/204 (0.00%)  1/210 (0.48%)  1/198 (0.51%) 
Pelvic venous thrombosis † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Peripheral artery aneurysm † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Peripheral artery stenosis † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Phlebitis deep † 1  0/204 (0.00%)  1/210 (0.48%)  0/198 (0.00%) 
Shock haemorrhagic † 1  0/204 (0.00%)  1/210 (0.48%)  3/198 (1.52%) 
Subclavian vein thrombosis † 1  1/204 (0.49%)  0/210 (0.00%)  0/198 (0.00%) 
Thrombosis † 1  1/204 (0.49%)  1/210 (0.48%)  0/198 (0.00%) 
Vena cava thrombosis † 1  0/204 (0.00%)  0/210 (0.00%)  1/198 (0.51%) 
Venous thrombosis † 1  1/204 (0.49%)  0/210 (0.00%)  1/198 (0.51%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tac+MPA Tac+Certican CycA+Certican
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   200/204 (98.04%)   205/210 (97.62%)   196/198 (98.99%) 
Blood and lymphatic system disorders       
Anaemia † 1  44/204 (21.57%)  53/210 (25.24%)  58/198 (29.29%) 
Leukopenia † 1  34/204 (16.67%)  17/210 (8.10%)  11/198 (5.56%) 
Thrombocytopenia † 1  8/204 (3.92%)  20/210 (9.52%)  20/198 (10.10%) 
Cardiac disorders       
Tachycardia † 1  14/204 (6.86%)  10/210 (4.76%)  10/198 (5.05%) 
Gastrointestinal disorders       
Abdominal pain † 1  16/204 (7.84%)  18/210 (8.57%)  18/198 (9.09%) 
Abdominal pain upper † 1  14/204 (6.86%)  19/210 (9.05%)  12/198 (6.06%) 
Constipation † 1  71/204 (34.80%)  69/210 (32.86%)  81/198 (40.91%) 
Diarrhoea † 1  19/204 (9.31%)  17/210 (8.10%)  6/198 (3.03%) 
Dyspepsia † 1  14/204 (6.86%)  17/210 (8.10%)  9/198 (4.55%) 
Flatulence † 1  24/204 (11.76%)  35/210 (16.67%)  25/198 (12.63%) 
Nausea † 1  46/204 (22.55%)  44/210 (20.95%)  42/198 (21.21%) 
Vomiting † 1  27/204 (13.24%)  22/210 (10.48%)  22/198 (11.11%) 
General disorders       
Impaired healing † 1  5/204 (2.45%)  13/210 (6.19%)  15/198 (7.58%) 
Oedema † 1  11/204 (5.39%)  9/210 (4.29%)  8/198 (4.04%) 
Oedema peripheral † 1  62/204 (30.39%)  82/210 (39.05%)  99/198 (50.00%) 
Immune system disorders       
Kidney transplant rejection † 1  8/204 (3.92%)  9/210 (4.29%)  14/198 (7.07%) 
Infections and infestations       
BK virus infection † 1  45/204 (22.06%)  36/210 (17.14%)  18/198 (9.09%) 
Bronchitis † 1  13/204 (6.37%)  5/210 (2.38%)  4/198 (2.02%) 
Cytomegalovirus infection † 1  33/204 (16.18%)  11/210 (5.24%)  3/198 (1.52%) 
Diarrhoea infectious † 1  56/204 (27.45%)  40/210 (19.05%)  29/198 (14.65%) 
Nasopharyngitis † 1  29/204 (14.22%)  31/210 (14.76%)  21/198 (10.61%) 
Urinary tract infection † 1  81/204 (39.71%)  74/210 (35.24%)  72/198 (36.36%) 
Injury, poisoning and procedural complications       
Complications of transplanted kidney † 1  28/204 (13.73%)  36/210 (17.14%)  43/198 (21.72%) 
Procedural pain † 1  26/204 (12.75%)  25/210 (11.90%)  21/198 (10.61%) 
Wound complication † 1  68/204 (33.33%)  64/210 (30.48%)  56/198 (28.28%) 
Investigations       
Blood creatinine increased † 1  25/204 (12.25%)  27/210 (12.86%)  26/198 (13.13%) 
Blood glucose increased † 1  6/204 (2.94%)  15/210 (7.14%)  8/198 (4.04%) 
C-reactive protein increased † 1  9/204 (4.41%)  15/210 (7.14%)  13/198 (6.57%) 
Haemoglobin decreased † 1  9/204 (4.41%)  11/210 (5.24%)  9/198 (4.55%) 
Metabolism and nutrition disorders       
Diabetes mellitus † 1  24/204 (11.76%)  33/210 (15.71%)  24/198 (12.12%) 
Dyslipidaemia † 1  2/204 (0.98%)  11/210 (5.24%)  7/198 (3.54%) 
Fluid overload † 1  7/204 (3.43%)  7/210 (3.33%)  13/198 (6.57%) 
Hypercalcaemia † 1  16/204 (7.84%)  16/210 (7.62%)  13/198 (6.57%) 
Hypercholesterolaemia † 1  5/204 (2.45%)  16/210 (7.62%)  17/198 (8.59%) 
Hyperglycaemia † 1  12/204 (5.88%)  20/210 (9.52%)  25/198 (12.63%) 
Hyperkalaemia † 1  65/204 (31.86%)  53/210 (25.24%)  58/198 (29.29%) 
Hyperlipidaemia † 1  8/204 (3.92%)  13/210 (6.19%)  23/198 (11.62%) 
Hyperphosphataemia † 1  5/204 (2.45%)  7/210 (3.33%)  12/198 (6.06%) 
Hypertriglyceridaemia † 1  3/204 (1.47%)  13/210 (6.19%)  10/198 (5.05%) 
Hyperuricaemia † 1  20/204 (9.80%)  10/210 (4.76%)  14/198 (7.07%) 
Hypocalcaemia † 1  20/204 (9.80%)  27/210 (12.86%)  17/198 (8.59%) 
Hypokalaemia † 1  33/204 (16.18%)  37/210 (17.62%)  41/198 (20.71%) 
Hypophosphataemia † 1  23/204 (11.27%)  36/210 (17.14%)  30/198 (15.15%) 
Iron deficiency † 1  6/204 (2.94%)  8/210 (3.81%)  10/198 (5.05%) 
Metabolic acidosis † 1  24/204 (11.76%)  25/210 (11.90%)  21/198 (10.61%) 
Vitamin D deficiency † 1  21/204 (10.29%)  20/210 (9.52%)  14/198 (7.07%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  4/204 (1.96%)  7/210 (3.33%)  11/198 (5.56%) 
Back pain † 1  17/204 (8.33%)  16/210 (7.62%)  10/198 (5.05%) 
Muscle spasms † 1  9/204 (4.41%)  11/210 (5.24%)  7/198 (3.54%) 
Nervous system disorders       
Headache † 1  15/204 (7.35%)  25/210 (11.90%)  15/198 (7.58%) 
Tremor † 1  30/204 (14.71%)  22/210 (10.48%)  9/198 (4.55%) 
Psychiatric disorders       
Anxiety † 1  8/204 (3.92%)  15/210 (7.14%)  9/198 (4.55%) 
Insomnia † 1  41/204 (20.10%)  39/210 (18.57%)  24/198 (12.12%) 
Sleep disorder † 1  22/204 (10.78%)  21/210 (10.00%)  22/198 (11.11%) 
Renal and urinary disorders       
Dysuria † 1  14/204 (6.86%)  14/210 (6.67%)  14/198 (7.07%) 
Haematuria † 1  14/204 (6.86%)  19/210 (9.05%)  13/198 (6.57%) 
Leukocyturia † 1  14/204 (6.86%)  13/210 (6.19%)  8/198 (4.04%) 
Nocturia † 1  12/204 (5.88%)  11/210 (5.24%)  14/198 (7.07%) 
Pollakiuria † 1  9/204 (4.41%)  11/210 (5.24%)  9/198 (4.55%) 
Proteinuria † 1  24/204 (11.76%)  26/210 (12.38%)  30/198 (15.15%) 
Renal impairment † 1  15/204 (7.35%)  13/210 (6.19%)  8/198 (4.04%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  11/204 (5.39%)  15/210 (7.14%)  14/198 (7.07%) 
Dyspnoea † 1  21/204 (10.29%)  22/210 (10.48%)  19/198 (9.60%) 
Skin and subcutaneous tissue disorders       
Acne † 1  3/204 (1.47%)  11/210 (5.24%)  4/198 (2.02%) 
Surgical and medical procedures       
Renal transplant † 1  8/204 (3.92%)  9/210 (4.29%)  17/198 (8.59%) 
Vascular disorders       
Haematoma † 1  10/204 (4.90%)  16/210 (7.62%)  17/198 (8.59%) 
Hypertension † 1  52/204 (25.49%)  62/210 (29.52%)  57/198 (28.79%) 
Hypotension † 1  13/204 (6.37%)  11/210 (5.24%)  16/198 (8.08%) 
Lymphocele † 1  20/204 (9.80%)  22/210 (10.48%)  31/198 (15.66%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
[Not Specified]
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.
Other disclosure agreement that restricts the right of the PI to discuss or publish trail results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigation from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-779-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01843348    
Other Study ID Numbers: CRAD001ADE44
2011-005238-21 ( EudraCT Number )
First Submitted: April 18, 2013
First Posted: April 30, 2013
Results First Submitted: March 21, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017