Trial Outcomes & Findings for Study Evaluating Sirolimus in Kidney Transplant Recipients (NCT NCT00195273)
NCT ID: NCT00195273
Last Updated: 2010-04-28
Results Overview
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
12 months
Results posted on
2010-04-28
Participant Flow
Patients were recruited in Sweden from November 2004 to September 2007.
Prior to enrollment in study, patients were screened for eligibility. If eligibility criteria were met, patients were enrolled and randomized.
Participant milestones
| Measure |
Sirolimus
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
10
|
16
|
|
Overall Study
NOT COMPLETED
|
21
|
14
|
Reasons for withdrawal
| Measure |
Sirolimus
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
9
|
|
Overall Study
Protocol deviation
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Procedural complications
|
9
|
3
|
Baseline Characteristics
Study Evaluating Sirolimus in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Sirolimus
n=31 Participants
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
n=30 Participants
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.00 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
59.60 years
STANDARD_DEVIATION 10.10 • n=7 Participants
|
60.31 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All patients who completed 12 months of study drug.
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
Outcome measures
| Measure |
Sirolimus
n=20 Participants
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
n=20 Participants
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Mean Creatinine Clearance Rate
|
56.800 ml/min
Standard Deviation 21.522
|
53.449 ml/min
Standard Deviation 15.497
|
SECONDARY outcome
Timeframe: 3 and 12 monthsPopulation: All patients who received at least one dose of study drug.
The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.
Outcome measures
| Measure |
Sirolimus
n=31 Participants
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
n=30 Participants
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Number of Patients With Acute Rejection
3 months
|
3 patients
|
9 patients
|
|
Number of Patients With Acute Rejection
12 months
|
5 patients
|
10 patients
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All patients who received at least one dose of study drug.
Graft survival is measured by graft loss which is defined as removal of the transplant.
Outcome measures
| Measure |
Sirolimus
n=31 Participants
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
n=30 Participants
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Patient and Graft Survival
Patient survival
|
31 patients
|
29 patients
|
|
Patient and Graft Survival
Graft loss
|
0 patients
|
3 patients
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All patients who completed 3 months of study drug.
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
Outcome measures
| Measure |
Sirolimus
n=27 Participants
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
n=27 Participants
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Mean Creatinine Clearance Rate - 3 Months
|
55.200 ml/min
Standard Deviation 22.403
|
51.878 ml/min
Standard Deviation 15.974
|
Adverse Events
Sirolimus
Serious events: 26 serious events
Other events: 31 other events
Deaths: 0 deaths
Cyclosporine (CsA)
Serious events: 24 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sirolimus
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
2/31
|
6.7%
2/30
|
|
Blood and lymphatic system disorders
Lymphocele
|
12.9%
4/31
|
20.0%
6/30
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31
|
3.3%
1/30
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Melaena
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
General malaise
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Hernia
|
6.5%
2/31
|
0.00%
0/30
|
|
General disorders
Oedema
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Pyrexia
|
0.00%
0/31
|
3.3%
1/30
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/31
|
3.3%
1/30
|
|
Immune system disorders
Kidney transplant rejection
|
12.9%
4/31
|
26.7%
8/30
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/31
|
6.7%
2/30
|
|
Infections and infestations
Brain abscess
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Cystitis
|
0.00%
0/31
|
6.7%
2/30
|
|
Infections and infestations
Cytomegalovirus infection
|
9.7%
3/31
|
16.7%
5/30
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Ear infection
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Escherichia sepsis
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Gastroenteritis
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Pneumonia
|
9.7%
3/31
|
13.3%
4/30
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Sepsis
|
3.2%
1/31
|
3.3%
1/30
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31
|
0.00%
0/30
|
|
Infections and infestations
Urosepsis
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Varicella
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
3.2%
1/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
3.2%
1/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Renal graft loss
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Wound complication
|
9.7%
3/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.5%
2/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Wound hemorrhage
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
Blood creatinine increased
|
3.2%
1/31
|
10.0%
3/30
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.2%
1/31
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31
|
0.00%
0/30
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Hydronephrosis
|
3.2%
1/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Renal artery stenosis
|
3.2%
1/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Renal impairment
|
9.7%
3/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Ureteric stenosis
|
3.2%
1/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
3.2%
1/31
|
0.00%
0/30
|
|
Vascular disorders
Aneurysm
|
3.2%
1/31
|
0.00%
0/30
|
|
Vascular disorders
Hematoma
|
3.2%
1/31
|
0.00%
0/30
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/31
|
3.3%
1/30
|
|
General disorders
Transplant changes
|
0.00%
0/31
|
3.3%
1/30
|
Other adverse events
| Measure |
Sirolimus
Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
Cyclosporine (CsA)
Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.
Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.
Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
48.4%
15/31
|
56.7%
17/30
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.9%
4/31
|
23.3%
7/30
|
|
Blood and lymphatic system disorders
Lymphocele
|
9.7%
3/31
|
10.0%
3/30
|
|
Cardiac disorders
Arrhythmia
|
29.0%
9/31
|
20.0%
6/30
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31
|
3.3%
1/30
|
|
Cardiac disorders
Bradycardia
|
19.4%
6/31
|
10.0%
3/30
|
|
Cardiac disorders
Palpitations
|
3.2%
1/31
|
3.3%
1/30
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
1/31
|
3.3%
1/30
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/31
|
3.3%
1/30
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/31
|
3.3%
1/30
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/31
|
3.3%
1/30
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/31
|
3.3%
1/30
|
|
Ear and labyrinth disorders
Ear pain
|
3.2%
1/31
|
0.00%
0/30
|
|
Endocrine disorders
Hyperaldosteronism
|
0.00%
0/31
|
3.3%
1/30
|
|
Eye disorders
Eye edema
|
3.2%
1/31
|
0.00%
0/30
|
|
Eye disorders
Visual acuity reduced
|
6.5%
2/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31
|
10.0%
3/30
|
|
Gastrointestinal disorders
Constipation
|
12.9%
4/31
|
23.3%
7/30
|
|
Gastrointestinal disorders
Diarrhea
|
22.6%
7/31
|
6.7%
2/30
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastritis
|
3.2%
1/31
|
10.0%
3/30
|
|
Gastrointestinal disorders
Gastrointestinal disorder general
|
3.2%
1/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/31
|
6.7%
2/30
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Hemorrhodial hemorrhage
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.7%
3/31
|
6.7%
2/30
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Intra-abdominal hematoma
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Lip ulceration
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/31
|
6.7%
2/30
|
|
Gastrointestinal disorders
Nausea
|
22.6%
7/31
|
33.3%
10/30
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastric refulx
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Tongue ulceration
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31
|
6.7%
2/30
|
|
General disorders
Calcinosis
|
0.00%
0/31
|
3.3%
1/30
|
|
General disorders
Chest pain
|
3.2%
1/31
|
3.3%
1/30
|
|
General disorders
Chills
|
3.2%
1/31
|
6.7%
2/30
|
|
General disorders
Discomfort
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Fatigue
|
3.2%
1/31
|
6.7%
2/30
|
|
General disorders
Feeling abnormal
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Feeling cold
|
0.00%
0/31
|
3.3%
1/30
|
|
General disorders
Fibrosis
|
0.00%
0/31
|
3.3%
1/30
|
|
General disorders
Hernia
|
3.2%
1/31
|
3.3%
1/30
|
|
General disorders
Impaired healing
|
12.9%
4/31
|
3.3%
1/30
|
|
General disorders
Malaise
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Necrosis
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Oedema
|
25.8%
8/31
|
13.3%
4/30
|
|
General disorders
Adema peripheral
|
32.3%
10/31
|
30.0%
9/30
|
|
General disorders
Pyrexia
|
9.7%
3/31
|
6.7%
2/30
|
|
General disorders
Vessel puncture site hemorrhage
|
0.00%
0/31
|
3.3%
1/30
|
|
Immune system disorders
Hypersenstivity
|
0.00%
0/31
|
3.3%
1/30
|
|
Immune system disorders
Kidney transplant rejection
|
9.7%
3/31
|
26.7%
8/30
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Bronchitis
|
12.9%
4/31
|
3.3%
1/30
|
|
Infections and infestations
Candidiasis
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Candiduria
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Citrobacter infection
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Clostridial infection
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Cystitis
|
12.9%
4/31
|
13.3%
4/30
|
|
Infections and infestations
Cytomegalovirus infection
|
9.7%
3/31
|
20.0%
6/30
|
|
Infections and infestations
Ear infection
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Folliculitis
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Fungal infection
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Herpes simplex
|
6.5%
2/31
|
6.7%
2/30
|
|
Infections and infestations
Herpes virus infection
|
3.2%
1/31
|
6.7%
2/30
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/31
|
6.7%
2/30
|
|
Infections and infestations
Human polyomavirus
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Infection
|
6.5%
2/31
|
3.3%
1/30
|
|
Infections and infestations
Viral laryngitis
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Nasopharyngitis
|
12.9%
4/31
|
13.3%
4/30
|
|
Infections and infestations
Oral candidiasis
|
12.9%
4/31
|
6.7%
2/30
|
|
Infections and infestations
Oral fungal infection
|
3.2%
1/31
|
3.3%
1/30
|
|
Infections and infestations
Oral herpes
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Orchitis
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Pneumonia
|
9.7%
3/31
|
0.00%
0/30
|
|
Infections and infestations
Postoperative wound infection
|
3.2%
1/31
|
0.00%
0/30
|
|
Infections and infestations
Sepsis
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31
|
3.3%
1/30
|
|
Infections and infestations
Transplant failure
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/31
|
3.3%
1/30
|
|
Infections and infestations
Urinary tract infection
|
25.8%
8/31
|
13.3%
4/30
|
|
Infections and infestations
Wound infection
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
6.5%
2/31
|
6.7%
2/30
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
6.5%
2/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.2%
1/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
3.2%
1/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
9.7%
3/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
3.2%
1/31
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Wound
|
3.2%
1/31
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Wound complications
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31
|
0.00%
0/30
|
|
Investigations
Antibody test positive
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
Blood creatinine increased
|
9.7%
3/31
|
10.0%
3/30
|
|
Investigations
Blood glucose increased
|
9.7%
3/31
|
6.7%
2/30
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
Blood parathyroid hormone
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
Blood potassium increased
|
3.2%
1/31
|
0.00%
0/30
|
|
Investigations
Blood urea increased
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
Blood uric acid increased
|
0.00%
0/31
|
3.3%
1/30
|
|
Investigations
C-reactive protein increased
|
3.2%
1/31
|
3.3%
1/30
|
|
Investigations
Cardiac murmur
|
6.5%
2/31
|
3.3%
1/30
|
|
Investigations
Cytomegalovirus test postive
|
0.00%
0/31
|
6.7%
2/30
|
|
Investigations
Hepatic enzyme increased
|
3.2%
1/31
|
0.00%
0/30
|
|
Investigations
Transaminases increased
|
3.2%
1/31
|
3.3%
1/30
|
|
Investigations
Weight increased
|
6.5%
2/31
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
19.4%
6/31
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/31
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.2%
1/31
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/31
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/31
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.7%
3/31
|
10.0%
3/30
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
12.9%
4/31
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.2%
1/31
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.5%
2/31
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.2%
1/31
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/31
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.2%
1/31
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.2%
1/31
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.5%
2/31
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Podagra
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31
|
10.0%
3/30
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
3.2%
1/31
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.2%
1/31
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.2%
1/31
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
3.2%
1/31
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
9.7%
3/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.5%
2/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/31
|
3.3%
1/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
3.2%
1/31
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.2%
1/31
|
6.7%
2/30
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Dizziness postural
|
6.5%
2/31
|
0.00%
0/30
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Headache
|
6.5%
2/31
|
3.3%
1/30
|
|
Nervous system disorders
Metabolic encephalopathy
|
3.2%
1/31
|
0.00%
0/30
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/31
|
6.7%
2/30
|
|
Nervous system disorders
Sciatica
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Syncope
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Tremor
|
0.00%
0/31
|
6.7%
2/30
|
|
Psychiatric disorders
Confusional state
|
3.2%
1/31
|
6.7%
2/30
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/31
|
3.3%
1/30
|
|
Psychiatric disorders
Insomina
|
6.5%
2/31
|
0.00%
0/30
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Hematuria
|
9.7%
3/31
|
6.7%
2/30
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Nocturia
|
3.2%
1/31
|
0.00%
0/30
|
|
Renal and urinary disorders
Oliguria
|
3.2%
1/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Proteinuria
|
6.5%
2/31
|
0.00%
0/30
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/31
|
3.3%
1/30
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.2%
1/31
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/31
|
3.3%
1/30
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/31
|
3.3%
1/30
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
4/31
|
16.7%
5/30
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
3/31
|
6.7%
2/30
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.9%
4/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal conjestion
|
3.2%
1/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airway disorder
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
1/31
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.2%
1/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
3.2%
1/31
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.2%
1/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.2%
1/31
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31
|
0.00%
0/30
|
|
Surgical and medical procedures
Renal surgery
|
3.2%
1/31
|
0.00%
0/30
|
|
Surgical and medical procedures
Urethral operation
|
0.00%
0/31
|
3.3%
1/30
|
|
Vascular disorders
Angiodysplasia
|
3.2%
1/31
|
0.00%
0/30
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
1/31
|
0.00%
0/30
|
|
Vascular disorders
Haematoma
|
12.9%
4/31
|
3.3%
1/30
|
|
Vascular disorders
Hemorrhage
|
3.2%
1/31
|
3.3%
1/30
|
|
Vascular disorders
Hypertension
|
12.9%
4/31
|
6.7%
2/30
|
|
General disorders
Injection site reaction
|
3.2%
1/31
|
0.00%
0/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER