Trial Outcomes & Findings for Everolimus in de Novo Heart Transplant Recipients (NCT NCT01017029)
NCT ID: NCT01017029
Last Updated: 2015-01-12
Results Overview
Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
182 participants
Primary outcome timeframe
6 months
Results posted on
2015-01-12
Participant Flow
Participant milestones
| Measure |
Immediate Introduction of Everolimus
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
92
|
|
Overall Study
COMPLETED
|
85
|
90
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Immediate Introduction of Everolimus
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Administrative problem
|
0
|
1
|
|
Overall Study
Death
|
3
|
1
|
Baseline Characteristics
Everolimus in de Novo Heart Transplant Recipients
Baseline characteristics by cohort
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.69 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
52.95 years
STANDARD_DEVIATION 10.19 • n=7 Participants
|
52.82 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
88 participants
n=5 Participants
|
88 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Weight
|
74.38 kilograms
STANDARD_DEVIATION 12.50 • n=5 Participants
|
71.18 kilograms
STANDARD_DEVIATION 12.75 • n=7 Participants
|
72.76 kilograms
STANDARD_DEVIATION 12.70 • n=5 Participants
|
|
Height
|
170.80 centimeters
STANDARD_DEVIATION 7.69 • n=5 Participants
|
170.10 centimeters
STANDARD_DEVIATION 8.03 • n=7 Participants
|
170.44 centimeters
STANDARD_DEVIATION 7.85 • n=5 Participants
|
|
Calculated BMI
|
25.44 kg/m2*
STANDARD_DEVIATION 3.65 • n=5 Participants
|
24.48 kg/m2*
STANDARD_DEVIATION 3.33 • n=7 Participants
|
24.95 kg/m2*
STANDARD_DEVIATION 3.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: safety population
Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm
Outcome measures
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group
|
40 participants
Interval 34.6 to 55.3
|
30 participants
Interval 23.0 to 42.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: safety population
Outcome measures
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group
Wound healing complication
|
10 participants
Interval 4.7 to 17.8
|
8 participants
Interval 2.9 to 14.5
|
|
Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group
Pleural effusion
|
1 participants
Interval 0.0 to 3.3
|
1 participants
Interval 0.0 to 3.2
|
|
Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group
Pericardial effusion
|
30 participants
Interval 23.9 to 43.5
|
18 participants
Interval 11.5 to 27.7
|
|
Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group
eGFR ≤ 30 mL/min/1.73 m2
|
7 participants
Interval 2.3 to 13.5
|
8 participants
Interval 2.9 to 14.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: safety population
Pericardial effusions: any pericardial effusion defined as at least moderate (i.e. measuring at least 2.0 cm in diastole, in the point of largest distance between the pericardial leaflets), with or without signs of hemodynamic compromise, or leading to drainage or to prolonged hospitalization. Pleural effusions: need for surgical drainage tubes for longer than 7 days after surgery and subsequent pleural effusions leading to drainage. CI = confidence interval, HR = hazard ratio, MDRD = Modification of Diet in Renal Disease
Outcome measures
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=87 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Hazard Cox's Model Analysis of Pericardial/Pleural Effusions
|
30 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: safety population
LDL = low density lipoprotein
Outcome measures
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group
Month 1
|
41 participants
Interval 35.7 to 56.4
|
38 participants
Interval 31.6 to 51.9
|
|
Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group
Month 3
|
37 participants
Interval 32.6 to 53.5
|
37 participants
Interval 30.2 to 50.2
|
|
Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group
Month 6
|
34 participants
Interval 28.1 to 48.3
|
36 participants
Interval 29.2 to 49.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: safety population
CMV infection is defined as pp65 antigenemia or DNAemia
Outcome measures
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group
CMV infections
|
46 participants
Interval 41.3 to 62.1
|
63 participants
Interval 59.0 to 78.0
|
|
Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group
CMV syndrome/disease
|
3 participants
Interval 0.0 to 7.1
|
6 participants
Interval 1.5 to 11.6
|
SECONDARY outcome
Timeframe: 6 monthsComparison of 6-months cumulative incidence of composite treatment failure events (BPAR ≥ 2R, rejection with hemodynamic compromise, graft loss, or death) between delayed everolimus arm and immediate everolimus arm
Outcome measures
| Measure |
Immediate Introduction of Everolimus
n=89 Participants
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 Participants
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Participants With at Least One Occurrence of Composite Treatment Failure Events
|
33 participants
Interval 27.0 to 47.1
|
26 participants
Interval 19.1 to 37.5
|
Adverse Events
Immediate Introduction of Everolimus
Serious events: 35 serious events
Other events: 72 other events
Deaths: 0 deaths
Delayed Introduction of Everolimus
Serious events: 31 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Introduction of Everolimus
n=89 participants at risk
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 participants at risk
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Cardiac disorders
Cardiac tamponade
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Cardiac disorders
Pericardial effusion
|
13.5%
12/89 • 6 months
Safety population
|
4.3%
4/92 • 6 months
Safety population
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
General disorders
Concomitant disease progression
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
General disorders
Death
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
General disorders
Drug interaction
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
General disorders
Hyperpyrexia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
General disorders
Oedema peripheral
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
General disorders
Pyrexia
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
General disorders
Sudden death
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Cholecystitis and cholelithiasis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Immune system disorders
Transplant rejection
|
7.9%
7/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Infections and infestations
Cytomegalovirus infection
|
4.5%
4/89 • 6 months
Safety population
|
6.5%
6/92 • 6 months
Safety population
|
|
Infections and infestations
Cytomegalovirus syndrome
|
0.00%
0/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Infections and infestations
Endocarditis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Infection
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Septic shock
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Urinary tract infections
|
2.2%
2/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.4%
3/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Escherichia test positive
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
White blood cell count increased
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Nervous system disorders
Convulsion
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Headache
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Renal failure
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Renal failure acute
|
3.4%
3/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Reproductive system and breast disorders
Epididymitis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinitis
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.5%
4/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
2/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Hypertension
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Hypotension
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
Other adverse events
| Measure |
Immediate Introduction of Everolimus
n=89 participants at risk
Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
|
Delayed Introduction of Everolimus
n=92 participants at risk
Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.1%
9/89 • 6 months
Safety population
|
9.8%
9/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.0%
16/89 • 6 months
Safety population
|
7.6%
7/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Lymph node pain
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
3/89 • 6 months
Safety population
|
4.3%
4/92 • 6 months
Safety population
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
5/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Cardiac disorders
Chest pain
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Dilatation ventricular
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Cardiac disorders
Palpitations
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Cardiac disorders
Pericardial effusion
|
44.9%
40/89 • 6 months
Safety population
|
34.8%
32/92 • 6 months
Safety population
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
3/89 • 6 months
Safety population
|
4.3%
4/92 • 6 months
Safety population
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Endocrine disorders
Diabetes mellitus
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Endocrine disorders
Hyperthyroidism
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
General disorders
Chest pain
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
General disorders
Implant site haematoma
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
General disorders
Oedema
|
4.5%
4/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
General disorders
Oedema peripheral
|
5.6%
5/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
General disorders
Oedema perpheral
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
General disorders
Pyrexia
|
2.2%
2/89 • 6 months
Safety population
|
6.5%
6/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.2%
2/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Immune system disorders
Transplant rejection
|
31.5%
28/89 • 6 months
Safety population
|
25.0%
23/92 • 6 months
Safety population
|
|
Infections and infestations
Bronchitis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Candidiasis
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Cystitis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Infections and infestations
Cytomegalovirus infection
|
2.2%
2/89 • 6 months
Safety population
|
6.5%
6/92 • 6 months
Safety population
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Folliculitis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Gastroenteritis aerobacter
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Herpes simplex
|
2.2%
2/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Infections and infestations
Infection
|
2.2%
2/89 • 6 months
Safety population
|
5.4%
5/92 • 6 months
Safety population
|
|
Infections and infestations
Influenza
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Mediastinitis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Infections and infestations
Oral herpes
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Oral stomatitis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Parotitis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Pseudomonal infectios
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Infections and infestations
Toxoplasmosis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Infections and infestations
Urinary tract infection
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Infections and infestations
Urinary tract infections
|
6.7%
6/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Infections and infestations
Wound infection
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Sternal injury
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Tongue injury
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Injury, poisoning and procedural complications
Wound complication
|
9.0%
8/89 • 6 months
Safety population
|
8.7%
8/92 • 6 months
Safety population
|
|
Investigations
Blood alkaline phosphatase increased
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Blood creatine phosphokinase increased
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
Blood creatinine increased
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Blood culture positive
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Blood iron decreased
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Blood potassium descreased
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
Blood urea increased
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
CPK increase
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
CSF white blood cell count increased
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Haemoglobin decreased
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Hepatic enzyme increased
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
Muscle enzyme increased
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
Platelet count descreased
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Investigations
Transaminases
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
Transaminases increased
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Investigations
White blood cell count increased
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.5%
4/89 • 6 months
Safety population
|
6.5%
6/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.5%
4/89 • 6 months
Safety population
|
10.9%
10/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal pain
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
4.5%
4/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.2%
2/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Spinal column injury
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Spinal fracture
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Musculoskeletal and connective tissue disorders
Tendon rupture
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Nervous system disorders
Cognitive disorder
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Hemianopia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Hemicephalalgia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Nervous system disorders
Polyneuropathy
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Psychomotor hyperactivity
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Nervous system disorders
Vertigo positional
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Psychiatric disorders
Depression
|
2.2%
2/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Fluid retention
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Hypercreatininaemia
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/89 • 6 months
Safety population
|
5.4%
5/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Renal failure chronic
|
1.1%
1/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinitis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.2%
18/89 • 6 months
Safety population
|
27.2%
25/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infecion
|
1.1%
1/89 • 6 months
Safety population
|
3.3%
3/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Surgical and medical procedures
Transfusion
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/89 • 6 months
Safety population
|
2.2%
2/92 • 6 months
Safety population
|
|
Vascular disorders
Femoral artery aneurysm
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Vascular disorders
Hypertension
|
11.2%
10/89 • 6 months
Safety population
|
12.0%
11/92 • 6 months
Safety population
|
|
Vascular disorders
Hypotension
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Jugular vein thrombosis
|
3.4%
3/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Vascular disorders
Lymphocele
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Polypoidal choroidal vasculopathy
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
|
Vascular disorders
Retinal vein thrombosis
|
1.1%
1/89 • 6 months
Safety population
|
0.00%
0/92 • 6 months
Safety population
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/89 • 6 months
Safety population
|
1.1%
1/92 • 6 months
Safety population
|
Additional Information
Novartis
Pharmaceuticals
Phone: +1(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 disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER