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Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00154310
First received: September 8, 2005
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: January 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplantation
Interventions: Drug: Everolimus
Drug: Cyclosporine
Drug: Enteric-coated mycophenolate sodium
Drug: Corticosteroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was an open-label, randomized, parallel-group, multi-center study with two treatment groups, cyclosporine continuation and cyclosporine withdrawal starting from Month 4.5 post-transplant. Study started in June 2005 and ended in September 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Everolimus + Mycophenolate Sodium Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
Cyclosporine + Mycophenolate Sodium Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

Participant Flow:   Overall Study
    Everolimus + Mycophenolate Sodium   Cyclosporine + Mycophenolate Sodium
STARTED   155 [1]   145 
COMPLETED   118   117 
NOT COMPLETED   37   28 
Adverse Event                19                9 
Lack of Efficacy                5                4 
Protocol Violation                4                2 
Withdrawal by Subject                9                3 
Lost to Follow-up                0                8 
Administrative problems                0                1 
Death                0                1 
[1] "Started" indicates enrolled participants. Randomized participants for two arms are 154 and 146.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Everolimus + Mycophenolate Sodium Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
Cyclosporine + Mycophenolate Sodium Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
Total Total of all reporting groups

Baseline Measures
   Everolimus + Mycophenolate Sodium   Cyclosporine + Mycophenolate Sodium   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   145   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.9  (11.67)   46.7  (11.85)   46.8  (11.73) 
Gender 
[Units: Participants]
     
Female   53   59   112 
Male   102   86   188 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Renal Function (Nankivell Formula) at Month 12 Post Transplantation.   [ Time Frame: at Month 12 post transplantation ]

2.  Secondary:   Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death   [ Time Frame: Up to Month 12 ]

3.  Secondary:   Number of Participants With Occurrence of Treatment Failures   [ Time Frame: up to or at Month 12 ]

4.  Secondary:   Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12   [ Time Frame: Month 4.5 and Month 12 ]

5.  Secondary:   Number of Participants Who Experienced an Adverse Event or Serious Adverse Event   [ Time Frame: Aes from end of core study period (month 12) to end of follow-up period (month 60) ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Certican Certican
Sandimmun Optoral Sandimmun Optoral

Serious Adverse Events
    Certican   Sandimmun Optoral
Total, serious adverse events     
# participants affected / at risk   103/155 (66.45%)   93/145 (64.14%) 
Blood and lymphatic system disorders     
Hypochromic anaemia † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Leukocytosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Leukopenia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Thrombocytopenia † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Cardiac disorders     
Acute coronary syndrome † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Arrhythmia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Atrial fibrillation † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Cardiac arrest † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Cardiac failure chronic † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Coronary artery disease † 1     
# participants affected / at risk   1/155 (0.65%)   2/145 (1.38%) 
Myocardial infarction † 1     
# participants affected / at risk   3/155 (1.94%)   1/145 (0.69%) 
Myopericarditis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Supraventricular tachycardia † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Ventricular tachycardia † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Congenital, familial and genetic disorders     
Congenital cystic kidney disease † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Pyloric stenosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Ear and labyrinth disorders     
Deafness † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Tinnitus † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Endocrine disorders     
Hyperparathyroidism † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Hyperparathyroidism secondary † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Eye disorders     
Amaurosis fugax † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Colitis † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Constipation † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Diarrhoea † 1     
# participants affected / at risk   6/155 (3.87%)   4/145 (2.76%) 
Enteritis † 1     
# participants affected / at risk   2/155 (1.29%)   1/145 (0.69%) 
Gastric polyps † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Gastritis erosive † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Inguinal hernia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Nausea † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Periodontitis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Peritoneal fibrosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Peritoneal haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Peritonitis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Retroperitoneal haematoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Small intestinal perforation † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Subileus † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Vomiting † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
General disorders     
Catheter site haematoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Fat necrosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Generalised oedema † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Hernia † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Hernia obstructive † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Impaired healing † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Oedema peripheral † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Pyrexia † 1     
# participants affected / at risk   5/155 (3.23%)   1/145 (0.69%) 
Hepatobiliary disorders     
Hydrocholecystis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Immune system disorders     
Transplant rejection † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Infections and infestations     
Aspergilloma † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Bacterial infection † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Bronchitis † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Bronchopulmonary aspergillosis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Chronic sinusitis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Cystitis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Cytomegalovirus infection † 1     
# participants affected / at risk   6/155 (3.87%)   5/145 (3.45%) 
Diverticulitis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Endocarditis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Enterococcal infection † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Erysipelas † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Febrile infection † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Gastroenteritis † 1     
# participants affected / at risk   7/155 (4.52%)   4/145 (2.76%) 
Gastroenteritis salmonella † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Gastroenteritis viral † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Gastrointestinal infection † 1     
# participants affected / at risk   2/155 (1.29%)   1/145 (0.69%) 
Herpes zoster † 1     
# participants affected / at risk   0/155 (0.00%)   3/145 (2.07%) 
Human polyomavirus infection † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Infected lymphocele † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Infection † 1     
# participants affected / at risk   2/155 (1.29%)   1/145 (0.69%) 
Lung infection † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Nasopharyngitis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Pneumocystis jiroveci pneumonia † 1     
# participants affected / at risk   3/155 (1.94%)   2/145 (1.38%) 
Pneumonia † 1     
# participants affected / at risk   8/155 (5.16%)   16/145 (11.03%) 
Pyelonephritis † 1     
# participants affected / at risk   4/155 (2.58%)   3/145 (2.07%) 
Renal cyst infection † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Respiratory tract infection † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Sepsis † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Shunt infection † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Sinusitis † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Superinfection † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Tracheitis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Urinary tract infection † 1     
# participants affected / at risk   18/155 (11.61%)   14/145 (9.66%) 
Urosepsis † 1     
# participants affected / at risk   5/155 (3.23%)   4/145 (2.76%) 
Viral upper respiratory tract infection † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Wound infection † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Anastomotic complication † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Anastomotic haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Arteriovenous fistula thrombosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Chronic allograft nephropathy † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Complications of transplanted kidney † 1     
# participants affected / at risk   3/155 (1.94%)   7/145 (4.83%) 
Fat embolism † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Femur fracture † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Foot fracture † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Incision site haematoma † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Muscle rupture † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Operative haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Perirenal haematoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Post procedural haematoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Post procedural haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Postoperative hernia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Renal haematoma † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Renal lymphocele † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Seroma † 1     
# participants affected / at risk   3/155 (1.94%)   0/145 (0.00%) 
Shunt thrombosis † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Spinal compression fracture † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Subcutaneous haematoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Transplant failure † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Urethral injury † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Wound dehiscence † 1     
# participants affected / at risk   1/155 (0.65%)   4/145 (2.76%) 
Investigations     
Blood creatinine increased † 1     
# participants affected / at risk   10/155 (6.45%)   15/145 (10.34%) 
Blood urea increased † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Cytomegalovirus test † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Haemoglobin decreased † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Occult blood positive † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Transaminases increased † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   1/155 (0.65%)   3/145 (2.07%) 
Diabetes mellitus † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Fluid retention † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Hypercalcaemia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Hyperglycaemia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Hyperkalaemia † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Hyponatraemia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Tetany † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Arthropathy † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Haemarthrosis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Myopathy steroid † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Osteonecrosis † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Pain in extremity † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Rhabdomyolysis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Synovial cyst † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma † 1     
# participants affected / at risk   3/155 (1.94%)   2/145 (1.38%) 
Bladder cancer † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Bowen's disease † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Fibrous histiocytoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Kaposi's sarcoma † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Neoplasm skin † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Parathyroid tumour benign † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Prostate cancer † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Renal cell carcinoma † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Squamous cell carcinoma † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Thyroid neoplasm † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Uterine leiomyoma † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Nervous system disorders     
Aphasia † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Cerebrovascular accident † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Convulsion † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Psychiatric disorders     
Depression † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Dysphoria † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Psychiatric decompensation † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Renal and urinary disorders     
Focal segmental glomerulosclerosis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Hydronephrosis † 1     
# participants affected / at risk   3/155 (1.94%)   0/145 (0.00%) 
IgA nephropathy † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Nephritis autoimmune † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Nephropathy † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Nephropathy toxic † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Nephrosclerosis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Proteinuria † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Renal artery stenosis † 1     
# participants affected / at risk   3/155 (1.94%)   1/145 (0.69%) 
Renal disorder † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Renal failure † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Renal failure acute † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Renal haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Renal impairment † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Renal tubular disorder † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Ureteral necrosis † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Ureteric stenosis † 1     
# participants affected / at risk   3/155 (1.94%)   3/145 (2.07%) 
Urethral discharge † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Urethral perforation † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Urethral stenosis † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Urinary incontinence † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Urinary retention † 1     
# participants affected / at risk   2/155 (1.29%)   2/145 (1.38%) 
Urinary tract disorder † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Urinary tract obstruction † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Urinoma † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Vesicoureteric reflux † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Cervical dysplasia † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Ovarian cyst † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Pelvic congestion † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Postmenopausal haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Scrotal oedema † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Vaginal haemorrhage † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Bronchitis chronic † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Dyspnoea † 1     
# participants affected / at risk   0/155 (0.00%)   2/145 (1.38%) 
Interstitial lung disease † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Lung infiltration † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Pulmonary embolism † 1     
# participants affected / at risk   3/155 (1.94%)   1/145 (0.69%) 
Respiratory arrest † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Respiratory failure † 1     
# participants affected / at risk   1/155 (0.65%)   1/145 (0.69%) 
Stridor † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Skin and subcutaneous tissue disorders     
Erythema nodosum † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Pyoderma gangrenosum † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Rash † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Skin ulcer † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Surgical and medical procedures     
Kidney anastomosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Vascular disorders     
Arterial restenosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Deep vein thrombosis † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Haematoma † 1     
# participants affected / at risk   3/155 (1.94%)   2/145 (1.38%) 
Haemorrhage † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Hypertension † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Hypertensive crisis † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Hypotension † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Lymphocele † 1     
# participants affected / at risk   9/155 (5.81%)   14/145 (9.66%) 
Peripheral artery aneurysm † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Shock haemorrhagic † 1     
# participants affected / at risk   2/155 (1.29%)   0/145 (0.00%) 
Thrombosis † 1     
# participants affected / at risk   0/155 (0.00%)   1/145 (0.69%) 
Venous thrombosis † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Venous thrombosis limb † 1     
# participants affected / at risk   1/155 (0.65%)   0/145 (0.00%) 
Events were collected by systematic assessment
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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