Trial Outcomes & Findings for A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients (NCT NCT00369161)
NCT ID: NCT00369161
Last Updated: 2017-03-03
Results Overview
Renal function was assessed by calculated glomerular filtration rate (cGFR) using Modification of Diet in Renal Disease (MDRD)formula. GFR \[mL/min/1.73m\^2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R, where: * C is the serum concentration of creatinine \[mg/dL\], * A is patient age at sample collection date \[years\], * G=0.742 when gender is female, otherwise G=1, * R=1.21 when race is black, otherwise R=1
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
228 participants
Primary outcome timeframe
12 months post -transplant
Results posted on
2017-03-03
Participant Flow
Centers in 13 countries screened at least 1 patient: Argentina, Brazil, Chile, Czech Republic, France, Hungary, Mexico, The Netherlands, Poland, Portugal, South Africa, Spain,Turkey. Starting 27 June 2006 and ending 29 Dec 2008.
Participant milestones
| Measure |
Very Low Dose Tacrolimus
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
119
|
|
Overall Study
Intention to Treat (ITT)
|
107
|
117
|
|
Overall Study
COMPLETED
|
82
|
95
|
|
Overall Study
NOT COMPLETED
|
27
|
24
|
Reasons for withdrawal
| Measure |
Very Low Dose Tacrolimus
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
13
|
|
Overall Study
Abnormal laboratory value
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Graft loss
|
4
|
0
|
|
Overall Study
Administrative Problem
|
2
|
2
|
Baseline Characteristics
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Very Low Dose Tacrolimus
n=107 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
n=117 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 12.08 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months post -transplantPopulation: Modified Intent-to-treat (ITT) population i.e patients with an available cGFR at month 12.
Renal function was assessed by calculated glomerular filtration rate (cGFR) using Modification of Diet in Renal Disease (MDRD)formula. GFR \[mL/min/1.73m\^2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R, where: * C is the serum concentration of creatinine \[mg/dL\], * A is patient age at sample collection date \[years\], * G=0.742 when gender is female, otherwise G=1, * R=1.21 when race is black, otherwise R=1
Outcome measures
| Measure |
Very Low Dose Tacrolimus
n=92 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
n=105 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)
|
57.07 mL/min/1.73m^2
Standard Deviation 19.467
|
51.73 mL/min/1.73m^2
Standard Deviation 19.995
|
SECONDARY outcome
Timeframe: from Month 4 through to Month 12Population: Intention to treat (ITT) population.
Biopsy-proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy.
Outcome measures
| Measure |
Very Low Dose Tacrolimus
n=107 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
n=117 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Number of Participants With Incidence of Biopsy-proven Acute Rejection (BPAR)
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Month 12Population: Intention to treat (ITT) population.
Efficacy failure was a composite of BPAR, graft loss, death or lost to follow-up. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy. An allograft was presumed to be lost on the day a patient started dialysis and was unable to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss.
Outcome measures
| Measure |
Very Low Dose Tacrolimus
n=107 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
n=117 Participants
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Percentage of Participants With Efficacy Failure
Efficacy failure (Composite)
|
6.7 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Efficacy Failure
BPAR
|
2.7 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Efficacy Failure
Graft loss or death
|
4.0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Efficacy Failure
Graft Loss
|
1.3 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Efficacy Failure
Death
|
2.7 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Efficacy Failure
Lost To Follow-up
|
0.0 percentage of participants
|
1.1 percentage of participants
|
Adverse Events
Very Low Dose Tacrolimus
Serious events: 64 serious events
Other events: 103 other events
Deaths: 0 deaths
Low Dose Tacrolimus
Serious events: 61 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Very Low Dose Tacrolimus
n=109 participants at risk
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
n=119 participants at risk
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Cardiac disorders
Atrial flutter
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Cardiac disorders
Cardiac failure
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Cardiac disorders
Coronary artery stenosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Cardiac disorders
Left ventricular failure
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Giant cell epulis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Oesophagitis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
General disorders
Asthenia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
General disorders
Influenza like illness
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
General disorders
Multi-organ failure
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
General disorders
Oedema
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
General disorders
Oedema peripheral
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
General disorders
Pyrexia
|
2.8%
3/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Immune system disorders
Kidney transplant rejection
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Immune system disorders
Transplant rejection
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Abscess intestinal
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Acute tonsillitis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
BK virus infection
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Bronchitis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Clostridium difficile colitis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Cytomegalovirus infection
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Encephalitis viral
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Gastroenteritis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Hepatitis E
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Lung infection
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Pneumonia
|
2.8%
3/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Postoperative wound infection
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Sepsis
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Septic shock
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Sinusitis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Skin infection
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Superinfection
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Urinary tract infection
|
9.2%
10/109
All randomized patients who are also considered as safety population
|
10.9%
13/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Urosepsis
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Wound infection
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
7.3%
8/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Graft loss
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.8%
3/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Investigations
Blood creatinine increased
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
10.9%
13/119
All randomized patients who are also considered as safety population
|
|
Investigations
Cytomegalovirus test
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Investigations
Renal function test abnormal
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Investigations
Weight decreased
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Investigations
Weight increased
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.7%
4/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Convulsion
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Paraplegia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Sciatica
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Psychiatric disorders
Anxiety
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Bladder stenosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Haematuria
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Reflux nephropathy
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Renal impairment
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vasculitis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Hypertension
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Iliac artery stenosis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Ischaemia
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.00%
0/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Lymphocele
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Phlebitis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Thrombophlebitis
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Vasculitis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
0.84%
1/119
All randomized patients who are also considered as safety population
|
Other adverse events
| Measure |
Very Low Dose Tacrolimus
n=109 participants at risk
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
Low Dose Tacrolimus
n=119 participants at risk
The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.6%
29/109
All randomized patients who are also considered as safety population
|
23.5%
28/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
2/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Constipation
|
13.8%
15/109
All randomized patients who are also considered as safety population
|
18.5%
22/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
17/109
All randomized patients who are also considered as safety population
|
16.0%
19/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Nausea
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
General disorders
Oedema
|
8.3%
9/109
All randomized patients who are also considered as safety population
|
10.9%
13/119
All randomized patients who are also considered as safety population
|
|
General disorders
Oedema peripheral
|
22.9%
25/109
All randomized patients who are also considered as safety population
|
22.7%
27/119
All randomized patients who are also considered as safety population
|
|
General disorders
Pyrexia
|
10.1%
11/109
All randomized patients who are also considered as safety population
|
14.3%
17/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
7.6%
9/119
All randomized patients who are also considered as safety population
|
|
Infections and infestations
Urinary tract infection
|
26.6%
29/109
All randomized patients who are also considered as safety population
|
28.6%
34/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
13.8%
15/109
All randomized patients who are also considered as safety population
|
9.2%
11/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Graft complication
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.0%
12/109
All randomized patients who are also considered as safety population
|
10.1%
12/119
All randomized patients who are also considered as safety population
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.6%
5/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Investigations
Blood creatinine increased
|
4.6%
5/109
All randomized patients who are also considered as safety population
|
7.6%
9/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Acidosis
|
5.5%
6/109
All randomized patients who are also considered as safety population
|
1.7%
2/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
9.2%
10/109
All randomized patients who are also considered as safety population
|
13.4%
16/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
12.8%
14/109
All randomized patients who are also considered as safety population
|
17.6%
21/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
21.1%
23/109
All randomized patients who are also considered as safety population
|
26.1%
31/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.8%
15/109
All randomized patients who are also considered as safety population
|
10.9%
13/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.8%
14/109
All randomized patients who are also considered as safety population
|
9.2%
11/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
13.8%
15/109
All randomized patients who are also considered as safety population
|
16.0%
19/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.5%
6/109
All randomized patients who are also considered as safety population
|
12.6%
15/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.5%
6/109
All randomized patients who are also considered as safety population
|
9.2%
11/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
4.2%
5/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
4/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.6%
17/109
All randomized patients who are also considered as safety population
|
13.4%
16/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.6%
5/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.8%
3/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
8/109
All randomized patients who are also considered as safety population
|
5.9%
7/119
All randomized patients who are also considered as safety population
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.5%
6/109
All randomized patients who are also considered as safety population
|
3.4%
4/119
All randomized patients who are also considered as safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
4/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Headache
|
10.1%
11/109
All randomized patients who are also considered as safety population
|
7.6%
9/119
All randomized patients who are also considered as safety population
|
|
Nervous system disorders
Tremor
|
5.5%
6/109
All randomized patients who are also considered as safety population
|
2.5%
3/119
All randomized patients who are also considered as safety population
|
|
Psychiatric disorders
Insomnia
|
11.0%
12/109
All randomized patients who are also considered as safety population
|
16.8%
20/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Dysuria
|
5.5%
6/109
All randomized patients who are also considered as safety population
|
6.7%
8/119
All randomized patients who are also considered as safety population
|
|
Renal and urinary disorders
Proteinuria
|
11.0%
12/109
All randomized patients who are also considered as safety population
|
7.6%
9/119
All randomized patients who are also considered as safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
1/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Skin and subcutaneous tissue disorders
Acne
|
13.8%
15/109
All randomized patients who are also considered as safety population
|
5.0%
6/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Hypertension
|
15.6%
17/109
All randomized patients who are also considered as safety population
|
16.0%
19/119
All randomized patients who are also considered as safety population
|
|
Vascular disorders
Lymphocele
|
6.4%
7/109
All randomized patients who are also considered as safety population
|
8.4%
10/119
All randomized patients who are also considered as safety population
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or publication of the trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER