Trial Outcomes & Findings for Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection (NCT NCT00300274)
NCT ID: NCT00300274
Last Updated: 2012-08-16
Results Overview
Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
721 participants
Primary outcome timeframe
12 Months
Results posted on
2012-08-16
Participant Flow
Participant milestones
| Measure |
Everolimus 1.5 mg
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
Everolimus 3.0 mg
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
282
|
168
|
271
|
|
Overall Study
Completed 12 Month
|
250
|
149
|
248
|
|
Overall Study
COMPLETED
|
236
|
141
|
226
|
|
Overall Study
NOT COMPLETED
|
46
|
27
|
45
|
Reasons for withdrawal
| Measure |
Everolimus 1.5 mg
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
Everolimus 3.0 mg
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
3
|
14
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
5
|
|
Overall Study
Death
|
31
|
20
|
25
|
|
Overall Study
Re-transplant
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
Baseline characteristics by cohort
| Measure |
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Total
n=721 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
51.1 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 11.88 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
574 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Intent-to-treat population included all randomized participants.
Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment.
Outcome measures
| Measure |
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Composite Efficacy Failure at 12 Months
|
35.1 Percentage of participants
|
33.6 Percentage of participants
|
35.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent-to-treat population included all randomized participants.
Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).
Outcome measures
| Measure |
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months
|
11.9 Percentage of participants
|
8.9 Percentage of participants
|
11.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Participants from the intent-to-treat population (all randomized participants) with data available for analysis.
GFR was calculated using the Modification of Diet and 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 age \[years\] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1
Outcome measures
| Measure |
Everolimus 3.0 mg
n=141 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=238 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=241 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months
|
59.78 mL/min/1.73^2
Standard Deviation 23.141
|
64.37 mL/min/1.73^2
Standard Deviation 28.365
|
59.21 mL/min/1.73^2
Standard Deviation 23.113
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).
Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.
Outcome measures
| Measure |
Everolimus 3.0 mg
n=37 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=101 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=88 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Change From Baseline in the Average Maximum Intimal Thickness at Month 12
|
0.04 mm
Standard Deviation 0.06
|
0.07 mm
Standard Deviation 0.110
|
0.03 mm
Standard Deviation 0.052
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).
Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.
Outcome measures
| Measure |
Everolimus 3.0 mg
n=37 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=101 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=88 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12
|
21.6 Percentage of participants
|
26.7 Percentage of participants
|
12.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent-to-treat population includes all randomized participants.
Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment.
Outcome measures
| Measure |
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12
AR associated with HDC
|
3.0 Percentage of participants
|
2.6 Percentage of participants
|
3.9 Percentage of participants
|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12
BPAR of ISHLT ≥ 3A
|
25.6 Percentage of participants
|
24.7 Percentage of participants
|
22.3 Percentage of participants
|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12
Death
|
10.1 Percentage of participants
|
4.8 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12
Graft loss/re-transplant
|
3.0 Percentage of participants
|
1.8 Percentage of participants
|
1.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Intent-to-treat population included all randomized participants.
Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment.
Outcome measures
| Measure |
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Composite Efficacy Failure at 24 Months
|
41.1 Percentage of participants
|
41.3 Percentage of participants
|
39.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Intent-to-treat population included all randomized participants.
Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).
Outcome measures
| Measure |
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months
|
16.1 Percentage of participants
|
15.1 Percentage of participants
|
15.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Participants from the intent-to-treat population (all randomized participants) with data available for analysis.
GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1
Outcome measures
| Measure |
Everolimus 3.0 mg
n=132 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=127 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=227 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months
|
61.84 mL/min/1.73^2
Standard Deviation 25.247
|
64.52 mL/min/1.73^2
Standard Deviation 23.764
|
59.50 mL/min/1.73^2
Standard Deviation 22.438
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Intent-to-treat population included all randomized participants.
Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment.
Outcome measures
| Measure |
Everolimus 3.0 mg
n=168 Participants
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=271 Participants
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
Everolimus 1.5 mg
n=282 Participants
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
|---|---|---|---|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24
AR associated with HDC
|
3.6 Percentage of participants
|
5.2 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24
BPAR of ISHLT grade ≥ 3A
|
28.6 Percentage of participants
|
27.3 Percentage of participants
|
24.1 Percentage of participants
|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24
Death
|
11.9 Percentage of participants
|
9.2 Percentage of participants
|
10.6 Percentage of participants
|
|
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24
Graft loss/re-transplant
|
3.0 Percentage of participants
|
3.7 Percentage of participants
|
2.5 Percentage of participants
|
Adverse Events
Everolimus 1.5 mg
Serious events: 209 serious events
Other events: 275 other events
Deaths: 0 deaths
Everolimus 3.0 mg
Serious events: 119 serious events
Other events: 165 other events
Deaths: 0 deaths
Mycophenolate Mofetil
Serious events: 168 serious events
Other events: 262 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus 1.5 mg
n=279 participants at risk
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
Everolimus 3.0 mg
n=167 participants at risk
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=268 participants at risk
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
5/279
|
3.0%
5/167
|
1.5%
4/268
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.36%
1/279
|
2.4%
4/167
|
0.75%
2/268
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Angina pectoris
|
1.4%
4/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Cardiac disorders
Aortic valve incompetence
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
7/279
|
1.8%
3/167
|
3.7%
10/268
|
|
Cardiac disorders
Atrial flutter
|
1.4%
4/279
|
0.60%
1/167
|
1.9%
5/268
|
|
Cardiac disorders
Atrial tachycardia
|
0.36%
1/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Cardiac disorders
Atrioventricular block complete
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Bradycardia
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
3/279
|
3.0%
5/167
|
1.1%
3/268
|
|
Cardiac disorders
Cardiac failure
|
0.36%
1/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
4/279
|
0.60%
1/167
|
1.5%
4/268
|
|
Cardiac disorders
Cardiac perforation
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Cardiac tamponade
|
1.8%
5/279
|
1.8%
3/167
|
1.5%
4/268
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Cardiogenic shock
|
0.72%
2/279
|
0.60%
1/167
|
2.2%
6/268
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Coronary artery occlusion
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Dilatation atrial
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.72%
2/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Cardiac disorders
Nodal arrhythmia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Nodal rhythm
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Palpitations
|
1.8%
5/279
|
0.00%
0/167
|
1.5%
4/268
|
|
Cardiac disorders
Pericardial cyst
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Pericardial effusion
|
13.6%
38/279
|
10.8%
18/167
|
4.5%
12/268
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Cardiac disorders
Pericarditis constrictive
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Pulseless electrical activity
|
0.72%
2/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.72%
2/279
|
1.8%
3/167
|
0.00%
0/268
|
|
Cardiac disorders
Right ventricular failure
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Cardiac disorders
Sinus arrest
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.72%
2/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Cardiac disorders
Tachycardia
|
0.36%
1/279
|
0.00%
0/167
|
1.1%
3/268
|
|
Cardiac disorders
Tricuspid valve incompetence
|
1.1%
3/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.36%
1/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Cardiac disorders
Ventricular asystole
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Cardiac disorders
Ventricular fibrillation
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Cardiac disorders
Ventricular tachycardia
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Eye disorders
Blindness
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Eye disorders
Retinal artery thrombosis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Eye disorders
Vision blurred
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Eye disorders
Visual impairment
|
0.00%
0/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Abdominal distension
|
0.72%
2/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.4%
4/279
|
1.8%
3/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
2/279
|
1.2%
2/167
|
1.1%
3/268
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
5/279
|
1.2%
2/167
|
1.9%
5/268
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Enteritis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/279
|
0.60%
1/167
|
1.1%
3/268
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Hernial eventration
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Ileitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Megacolon
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/279
|
2.4%
4/167
|
2.6%
7/268
|
|
Gastrointestinal disorders
Odynophagia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Oesophagitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Oral disorder
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Stomatitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Stomatitis necrotising
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/279
|
1.8%
3/167
|
1.9%
5/268
|
|
General disorders
Asthenia
|
1.1%
3/279
|
0.00%
0/167
|
0.37%
1/268
|
|
General disorders
Cardiac death
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
General disorders
Catheter site haematoma
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
General disorders
Chest pain
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Chills
|
1.1%
3/279
|
2.4%
4/167
|
0.75%
2/268
|
|
General disorders
Concomitant disease progression
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
General disorders
Crepitations
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
General disorders
Device breakage
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
General disorders
Device malfunction
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Fatigue
|
0.72%
2/279
|
1.2%
2/167
|
2.2%
6/268
|
|
General disorders
Feeling hot
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Generalised oedema
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Hyperpyrexia
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Hyperthermia
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Hypothermia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
General disorders
Impaired healing
|
0.00%
0/279
|
0.60%
1/167
|
0.75%
2/268
|
|
General disorders
Malaise
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
General disorders
Multi-organ failure
|
2.2%
6/279
|
1.8%
3/167
|
1.9%
5/268
|
|
General disorders
Non-cardiac chest pain
|
2.9%
8/279
|
1.2%
2/167
|
1.1%
3/268
|
|
General disorders
Oedema
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
General disorders
Oedema peripheral
|
2.2%
6/279
|
3.0%
5/167
|
1.5%
4/268
|
|
General disorders
Pyrexia
|
4.3%
12/279
|
8.4%
14/167
|
3.7%
10/268
|
|
General disorders
Sudden cardiac death
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
General disorders
Sudden death
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
General disorders
Systemic inflammatory response syndrome
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Hepatobiliary disorders
Bile duct stone
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Hepatobiliary disorders
Cholecystitis
|
0.72%
2/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
3/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Immune system disorders
Drug hypersensitivity
|
0.72%
2/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Immune system disorders
Heart transplant rejection
|
7.2%
20/279
|
7.8%
13/167
|
9.7%
26/268
|
|
Immune system disorders
Hypersensitivity
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Immune system disorders
Transplant rejection
|
0.72%
2/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Abscess limb
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Infections and infestations
Abscess neck
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Acute pulmonary histoplasmosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Appendicitis
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Aspergillosis
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Bacteraemia
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Brain abscess
|
0.00%
0/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Infections and infestations
Bronchiolitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Bronchitis
|
0.36%
1/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.72%
2/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Infections and infestations
Candida pneumonia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Cellulitis
|
0.72%
2/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Infections and infestations
Cerebral aspergillosis
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Clostridial infection
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Clostridium difficile colitis
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Infections and infestations
Cytomegalovirus gastritis
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Infections and infestations
Cytomegalovirus infection
|
1.1%
3/279
|
3.0%
5/167
|
3.7%
10/268
|
|
Infections and infestations
Cytomegalovirus syndrome
|
0.00%
0/279
|
0.00%
0/167
|
1.1%
3/268
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.36%
1/279
|
1.2%
2/167
|
3.0%
8/268
|
|
Infections and infestations
Device related infection
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Device related sepsis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Endocarditis
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Enterococcal infection
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Escherichia sepsis
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Fungal abscess central nervous system
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Fungal infection
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Fungal peritonitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Fungal sepsis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Gastroenteritis
|
1.4%
4/279
|
0.60%
1/167
|
1.5%
4/268
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
3/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
H1N1 influenza
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Herpes virus infection
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Herpes zoster
|
0.72%
2/279
|
0.00%
0/167
|
1.1%
3/268
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Incision site infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Infection
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Influenza
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Infections and infestations
Intraspinal abscess
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Listeriosis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Lobar pneumonia
|
0.36%
1/279
|
0.60%
1/167
|
1.1%
3/268
|
|
Infections and infestations
Lower respiratory tract infection
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Infections and infestations
Lung abscess
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Lung infection
|
1.8%
5/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Lung infection pseudomonal
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Mediastinitis
|
1.4%
4/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Mycobacterium chelonei infection
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Myocarditis mycotic
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Oral herpes
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/279
|
1.8%
3/167
|
0.75%
2/268
|
|
Infections and infestations
Pericarditis fungal
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumococcal sepsis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.36%
1/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumonia
|
5.4%
15/279
|
6.6%
11/167
|
3.0%
8/268
|
|
Infections and infestations
Pneumonia bacterial
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/279
|
0.60%
1/167
|
1.1%
3/268
|
|
Infections and infestations
Pneumonia escherichia
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumonia haemophilus
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumonia klebsiella
|
0.36%
1/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.1%
3/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Infections and infestations
Pneumonia primary atypical
|
0.72%
2/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Postoperative wound infection
|
1.8%
5/279
|
3.0%
5/167
|
0.75%
2/268
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Purulent pericarditis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Pyothorax
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Sepsis
|
2.5%
7/279
|
3.6%
6/167
|
0.75%
2/268
|
|
Infections and infestations
Sepsis syndrome
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Septic embolus
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Septic shock
|
1.4%
4/279
|
1.8%
3/167
|
0.75%
2/268
|
|
Infections and infestations
Sinusitis
|
1.1%
3/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Infections and infestations
Skin infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Staphylococcal mediastinitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Staphylococcal sepsis
|
1.1%
3/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Tooth infection
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
3/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Infections and infestations
Urinary tract infection
|
1.8%
5/279
|
0.00%
0/167
|
1.9%
5/268
|
|
Infections and infestations
Urosepsis
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Varicella
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Viral infection
|
1.1%
3/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.8%
5/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Infections and infestations
Wound infection
|
0.36%
1/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Infections and infestations
Wound infection staphylococcal
|
0.36%
1/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Complications of transplanted heart
|
0.72%
2/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Contusion
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Fall
|
0.72%
2/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Head injury
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.1%
3/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.72%
2/279
|
0.00%
0/167
|
1.5%
4/268
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Seroma
|
1.4%
4/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.36%
1/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Investigations
Atrial pressure increased
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Blood creatine phosphokinase increased
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Investigations
Blood creatinine increased
|
1.4%
4/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Investigations
Blood potassium increased
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Blood pressure increased
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Investigations
Cells in urine
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Central venous pressure increased
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Investigations
Culture wound positive
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Haemoglobin decreased
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Investigations
Immunosuppressant drug level
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Investigations
Immunosuppressant drug level decreased
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Immunosuppressant drug level increased
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Investigations
Left ventricular end-diastolic pressure increased
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Investigations
Liver function test abnormal
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Sputum culture positive
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
Troponin increased
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Investigations
Weight increased
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Investigations
White blood cell count decreased
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
3/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.2%
6/279
|
3.6%
6/167
|
2.2%
6/268
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
3/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.36%
1/279
|
1.2%
2/167
|
1.5%
4/268
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
3/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
3/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.72%
2/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/279
|
1.8%
3/167
|
1.5%
4/268
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.36%
1/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.36%
1/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
4/279
|
1.8%
3/167
|
0.75%
2/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoproliferative disorder
|
0.00%
0/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Nervous system disorders
Amnesia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Nervous system disorders
Aphasia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Ataxia
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Brain injury
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.72%
2/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Cerebrovascular accident
|
0.72%
2/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Coma
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Convulsion
|
1.4%
4/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Dizziness
|
0.72%
2/279
|
1.8%
3/167
|
0.75%
2/268
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Grand mal convulsion
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Headache
|
0.72%
2/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Hemiparesis
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Nervous system disorders
Hypoaesthesia
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Nervous system disorders
Migraine
|
0.36%
1/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Nervous system disorders
Neurological symptom
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Nervous system disorders
Neuropathy peripheral
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Nervous system disorders
Polyneuropathy
|
0.72%
2/279
|
0.60%
1/167
|
1.5%
4/268
|
|
Nervous system disorders
Sciatica
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Syncope
|
1.8%
5/279
|
0.60%
1/167
|
2.2%
6/268
|
|
Nervous system disorders
Thalamic infarction
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/279
|
1.8%
3/167
|
0.37%
1/268
|
|
Nervous system disorders
Tremor
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Psychiatric disorders
Abnormal behaviour
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/279
|
0.60%
1/167
|
1.1%
3/268
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Psychiatric disorders
Delirium
|
0.00%
0/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Psychiatric disorders
Depression
|
0.36%
1/279
|
0.60%
1/167
|
0.75%
2/268
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/279
|
0.60%
1/167
|
1.1%
3/268
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Renal and urinary disorders
Haematuria
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Polyuria
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Proteinuria
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Renal failure
|
3.6%
10/279
|
0.00%
0/167
|
1.1%
3/268
|
|
Renal and urinary disorders
Renal failure acute
|
4.3%
12/279
|
7.8%
13/167
|
4.9%
13/268
|
|
Renal and urinary disorders
Renal failure chronic
|
0.36%
1/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
3/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Reproductive system and breast disorders
Colpocele
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Reproductive system and breast disorders
Epididymitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Reproductive system and breast disorders
Oedema genital
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.72%
2/279
|
1.8%
3/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
14/279
|
4.8%
8/167
|
3.0%
8/268
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.36%
1/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.1%
3/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/279
|
1.2%
2/167
|
0.37%
1/268
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.72%
2/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.7%
13/279
|
2.4%
4/167
|
2.2%
6/268
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
5/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
5/279
|
2.4%
4/167
|
0.75%
2/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
4/279
|
1.2%
2/167
|
0.75%
2/268
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Surgical and medical procedures
Incisional drainage
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Vascular disorders
Angiodysplasia
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Arteriovenous fistula
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
3/279
|
1.2%
2/167
|
1.1%
3/268
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Vascular disorders
Flushing
|
0.36%
1/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Vascular disorders
Haematoma
|
0.72%
2/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Vascular disorders
Haemodynamic instability
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Vascular disorders
Hypertension
|
1.4%
4/279
|
1.2%
2/167
|
0.00%
0/268
|
|
Vascular disorders
Hypertensive crisis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Hypotension
|
1.1%
3/279
|
3.0%
5/167
|
1.5%
4/268
|
|
Vascular disorders
Intermittent claudication
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Vascular disorders
Jugular vein thrombosis
|
0.36%
1/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Vascular disorders
Lymphocele
|
1.8%
5/279
|
0.60%
1/167
|
0.37%
1/268
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/279
|
0.60%
1/167
|
0.00%
0/268
|
|
Vascular disorders
Lymphorrhoea
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/279
|
0.00%
0/167
|
0.75%
2/268
|
|
Vascular disorders
Phlebitis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.36%
1/279
|
0.00%
0/167
|
0.00%
0/268
|
|
Vascular disorders
Thrombosis
|
0.00%
0/279
|
0.00%
0/167
|
0.37%
1/268
|
|
Vascular disorders
Venous thrombosis limb
|
0.36%
1/279
|
0.00%
0/167
|
0.75%
2/268
|
Other adverse events
| Measure |
Everolimus 1.5 mg
n=279 participants at risk
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
|
Everolimus 3.0 mg
n=167 participants at risk
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
|
Mycophenolate Mofetil
n=268 participants at risk
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.6%
105/279
|
35.9%
60/167
|
27.6%
74/268
|
|
Blood and lymphatic system disorders
Leukocytosis
|
13.3%
37/279
|
16.2%
27/167
|
10.1%
27/268
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.9%
36/279
|
17.4%
29/167
|
25.0%
67/268
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
8/279
|
2.4%
4/167
|
5.6%
15/268
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
26/279
|
15.0%
25/167
|
9.3%
25/268
|
|
Cardiac disorders
Atrial fibrillation
|
7.2%
20/279
|
7.8%
13/167
|
8.2%
22/268
|
|
Cardiac disorders
Left ventricular hypertrophy
|
5.7%
16/279
|
3.0%
5/167
|
4.5%
12/268
|
|
Cardiac disorders
Mitral valve incompetence
|
5.4%
15/279
|
4.2%
7/167
|
6.7%
18/268
|
|
Cardiac disorders
Palpitations
|
4.3%
12/279
|
8.4%
14/167
|
5.2%
14/268
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
93/279
|
30.5%
51/167
|
25.7%
69/268
|
|
Cardiac disorders
Sinus tachycardia
|
4.7%
13/279
|
5.4%
9/167
|
2.6%
7/268
|
|
Cardiac disorders
Tachycardia
|
7.2%
20/279
|
8.4%
14/167
|
8.6%
23/268
|
|
Cardiac disorders
Tricuspid valve incompetence
|
10.0%
28/279
|
10.2%
17/167
|
9.0%
24/268
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
11/279
|
4.8%
8/167
|
6.3%
17/268
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
29/279
|
10.2%
17/167
|
9.7%
26/268
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
17/279
|
5.4%
9/167
|
6.3%
17/268
|
|
Gastrointestinal disorders
Constipation
|
25.1%
70/279
|
25.1%
42/167
|
23.5%
63/268
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
62/279
|
25.7%
43/167
|
25.0%
67/268
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
17/279
|
5.4%
9/167
|
6.0%
16/268
|
|
Gastrointestinal disorders
Nausea
|
22.9%
64/279
|
31.1%
52/167
|
26.9%
72/268
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
33/279
|
12.6%
21/167
|
16.8%
45/268
|
|
General disorders
Asthenia
|
5.7%
16/279
|
7.2%
12/167
|
7.8%
21/268
|
|
General disorders
Chills
|
4.3%
12/279
|
7.2%
12/167
|
4.9%
13/268
|
|
General disorders
Fatigue
|
14.0%
39/279
|
13.2%
22/167
|
18.7%
50/268
|
|
General disorders
Non-cardiac chest pain
|
13.6%
38/279
|
6.0%
10/167
|
9.7%
26/268
|
|
General disorders
Oedema peripheral
|
47.7%
133/279
|
41.3%
69/167
|
44.4%
119/268
|
|
General disorders
Pyrexia
|
16.8%
47/279
|
13.2%
22/167
|
14.2%
38/268
|
|
Immune system disorders
Heart transplant rejection
|
2.2%
6/279
|
1.2%
2/167
|
5.6%
15/268
|
|
Infections and infestations
Bronchitis
|
2.5%
7/279
|
4.2%
7/167
|
5.6%
15/268
|
|
Infections and infestations
Cytomegalovirus infection
|
5.0%
14/279
|
4.2%
7/167
|
9.3%
25/268
|
|
Infections and infestations
Herpes zoster
|
2.9%
8/279
|
2.4%
4/167
|
8.6%
23/268
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
35/279
|
7.2%
12/167
|
11.9%
32/268
|
|
Infections and infestations
Oral candidiasis
|
3.6%
10/279
|
1.8%
3/167
|
5.2%
14/268
|
|
Infections and infestations
Oral herpes
|
2.5%
7/279
|
5.4%
9/167
|
5.6%
15/268
|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
34/279
|
9.6%
16/167
|
11.9%
32/268
|
|
Infections and infestations
Urinary tract infection
|
6.5%
18/279
|
11.4%
19/167
|
7.5%
20/268
|
|
Injury, poisoning and procedural complications
Incision site pain
|
7.2%
20/279
|
11.4%
19/167
|
7.5%
20/268
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
5.0%
14/279
|
3.6%
6/167
|
2.6%
7/268
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
35/279
|
14.4%
24/167
|
11.9%
32/268
|
|
Investigations
Blood creatinine increased
|
9.0%
25/279
|
10.2%
17/167
|
6.7%
18/268
|
|
Investigations
Blood triglycerides increased
|
4.7%
13/279
|
5.4%
9/167
|
2.6%
7/268
|
|
Investigations
Cytomegalovirus test positive
|
1.4%
4/279
|
5.4%
9/167
|
6.7%
18/268
|
|
Investigations
Haemoglobin decreased
|
6.8%
19/279
|
3.6%
6/167
|
8.2%
22/268
|
|
Investigations
Weight increased
|
5.0%
14/279
|
3.0%
5/167
|
5.6%
15/268
|
|
Investigations
White blood cell count decreased
|
3.9%
11/279
|
7.2%
12/167
|
13.1%
35/268
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
10/279
|
6.6%
11/167
|
3.0%
8/268
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.2%
20/279
|
4.8%
8/167
|
8.2%
22/268
|
|
Metabolism and nutrition disorders
Fluid overload
|
16.8%
47/279
|
18.0%
30/167
|
16.0%
43/268
|
|
Metabolism and nutrition disorders
Gout
|
5.4%
15/279
|
3.6%
6/167
|
2.6%
7/268
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
13.6%
38/279
|
13.2%
22/167
|
8.6%
23/268
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.5%
32/279
|
12.6%
21/167
|
11.6%
31/268
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.2%
34/279
|
10.2%
17/167
|
12.7%
34/268
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.9%
22/279
|
5.4%
9/167
|
3.7%
10/268
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.7%
41/279
|
13.8%
23/167
|
11.2%
30/268
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.4%
15/279
|
6.0%
10/167
|
6.7%
18/268
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.0%
39/279
|
15.0%
25/167
|
11.9%
32/268
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.5%
21/279
|
12.0%
20/167
|
13.8%
37/268
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
23/279
|
7.8%
13/167
|
11.2%
30/268
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.3%
51/279
|
10.2%
17/167
|
15.7%
42/268
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.7%
41/279
|
12.6%
21/167
|
13.4%
36/268
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.8%
19/279
|
3.6%
6/167
|
3.7%
10/268
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.7%
16/279
|
2.4%
4/167
|
4.9%
13/268
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
14/279
|
5.4%
9/167
|
6.7%
18/268
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
24/279
|
6.6%
11/167
|
6.7%
18/268
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
28/279
|
5.4%
9/167
|
9.3%
25/268
|
|
Nervous system disorders
Dizziness
|
13.3%
37/279
|
11.4%
19/167
|
10.1%
27/268
|
|
Nervous system disorders
Headache
|
30.5%
85/279
|
23.4%
39/167
|
26.1%
70/268
|
|
Nervous system disorders
Paraesthesia
|
8.2%
23/279
|
6.0%
10/167
|
6.3%
17/268
|
|
Nervous system disorders
Tremor
|
20.8%
58/279
|
19.8%
33/167
|
22.4%
60/268
|
|
Psychiatric disorders
Anxiety
|
14.7%
41/279
|
13.2%
22/167
|
13.1%
35/268
|
|
Psychiatric disorders
Depression
|
9.7%
27/279
|
8.4%
14/167
|
9.7%
26/268
|
|
Psychiatric disorders
Insomnia
|
27.6%
77/279
|
19.2%
32/167
|
22.4%
60/268
|
|
Renal and urinary disorders
Renal failure
|
15.8%
44/279
|
15.0%
25/167
|
10.1%
27/268
|
|
Renal and urinary disorders
Renal impairment
|
8.2%
23/279
|
4.8%
8/167
|
4.9%
13/268
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.7%
16/279
|
3.6%
6/167
|
3.4%
9/268
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.4%
15/279
|
4.2%
7/167
|
7.5%
20/268
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
67/279
|
13.8%
23/167
|
19.0%
51/268
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.4%
54/279
|
15.0%
25/167
|
17.5%
47/268
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.7%
13/279
|
5.4%
9/167
|
6.0%
16/268
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
17/279
|
6.6%
11/167
|
3.4%
9/268
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
14/279
|
5.4%
9/167
|
3.4%
9/268
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.5%
21/279
|
5.4%
9/167
|
6.0%
16/268
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
23.3%
65/279
|
22.2%
37/167
|
21.3%
57/268
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.4%
15/279
|
2.4%
4/167
|
3.0%
8/268
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
15/279
|
3.0%
5/167
|
3.7%
10/268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.9%
11/279
|
6.0%
10/167
|
6.7%
18/268
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.2%
23/279
|
10.8%
18/167
|
10.4%
28/268
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.9%
8/279
|
5.4%
9/167
|
2.2%
6/268
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
15/279
|
10.2%
17/167
|
6.3%
17/268
|
|
Vascular disorders
Hypertension
|
47.3%
132/279
|
43.1%
72/167
|
46.6%
125/268
|
|
Vascular disorders
Hypotension
|
8.2%
23/279
|
7.8%
13/167
|
10.1%
27/268
|
|
Vascular disorders
Jugular vein thrombosis
|
5.0%
14/279
|
2.4%
4/167
|
1.9%
5/268
|
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.
- Publication restrictions are in place
Restriction type: OTHER