Trial Outcomes & Findings for 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients (NCT NCT01843348)
NCT ID: NCT01843348
Last Updated: 2017-05-01
Results Overview
To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula: GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
612 participants
Primary outcome timeframe
One year post transplant
Results posted on
2017-05-01
Participant Flow
Participant milestones
| Measure |
TAC+MPA
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
Cyclosporin A, Certican, corticosteroids and Simulect
|
|---|---|---|---|
|
Overall Study
STARTED
|
205
|
208
|
199
|
|
Overall Study
Safety Analysis Set (SAS)
|
204
|
210
|
198
|
|
Overall Study
Full Analysis Set (FAS)
|
205
|
208
|
199
|
|
Overall Study
Per Protocol Set (PPS)
|
147
|
111
|
80
|
|
Overall Study
COMPLETED
|
182
|
168
|
158
|
|
Overall Study
NOT COMPLETED
|
23
|
40
|
41
|
Reasons for withdrawal
| Measure |
TAC+MPA
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
Cyclosporin A, Certican, corticosteroids and Simulect
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
16
|
18
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
2
|
|
Overall Study
Death
|
5
|
3
|
4
|
|
Overall Study
Graft loss/retransplantation
|
5
|
8
|
11
|
|
Overall Study
Various reasons
|
4
|
9
|
6
|
Baseline Characteristics
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
TAC+MPA
n=205 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=208 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=199 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Total
n=612 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 12.74 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
411 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One year post transplantPopulation: Protocol analysis set comprised of participants who received at least one dose of study drug without major protocol deviaitons
To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula: GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set
Outcome measures
| Measure |
TAC+MPA
n=147 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=111 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=80 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
Month 3 - Day 61 to 136 (143,108,79)
|
66.36 mL/min per 1.73m²
Standard Deviation 16.672
|
61.21 mL/min per 1.73m²
Standard Deviation 14.771
|
62.22 mL/min per 1.73m²
Standard Deviation 16.196
|
—
|
—
|
|
Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
Month 6 - Day 137 to 228 (142,108,76)
|
68.05 mL/min per 1.73m²
Standard Deviation 16.994
|
62.76 mL/min per 1.73m²
Standard Deviation 16.763
|
63.17 mL/min per 1.73m²
Standard Deviation 16.789
|
—
|
—
|
|
Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
Month 1 - Day 1 to 60 (146,111,78)
|
62.62 mL/min per 1.73m²
Standard Deviation 16.931
|
60.54 mL/min per 1.73m²
Standard Deviation 17.310
|
59.47 mL/min per 1.73m²
Standard Deviation 16.754
|
—
|
—
|
|
Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
Month 9 - Day 229 to 319 (140,106,77)
|
69.47 mL/min per 1.73m²
Standard Deviation 16.251
|
64.68 mL/min per 1.73m²
Standard Deviation 15.507
|
62.89 mL/min per 1.73m²
Standard Deviation 14.947
|
—
|
—
|
|
Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
Month12 - Day 320 to 450 (147,111, 80)
|
70.41 mL/min per 1.73m²
Standard Deviation 16.514
|
63.34 mL/min per 1.73m²
Standard Deviation 16.986
|
61.51 mL/min per 1.73m²
Standard Deviation 16.942
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12 post transplantPopulation: Full analysis set includes all participants who received at least one dose of study drug.
Combined endpoint included: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)
Outcome measures
| Measure |
TAC+MPA
n=205 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=208 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=199 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
n=413 Participants
|
CycA+Certican -Tac+MPA - Difference Between Groups
n=404 Participants
|
|---|---|---|---|---|---|
|
Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12
BPAR or graft loss or death
|
9.8 Percentage of participants
|
13.0 Percentage of participants
|
24.6 Percentage of participants
|
3.2 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12
BPAR, graft loss, death, or loss of follow-up
|
15.6 Percentage of participants
|
22.6 Percentage of participants
|
32.7 Percentage of participants
|
7.0 Percentage of participants
|
17.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 12 post transplantPopulation: Full analysis set
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method = GFR=141 x min(Scr/κ, 1)α x max(Scr/κ, 1)1.209 x 0.993Age x 1.018 \[if female\] x 1.159 \[if black\] where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is 0.329 for females and 0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Outcome measures
| Measure |
TAC+MPA
n=181 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=166 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=158 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant
|
51.62 mL/min per 1.73m²
Interval 48.1 to 55.14
|
44.42 mL/min per 1.73m²
Interval 40.95 to 47.89
|
42.44 mL/min per 1.73m²
Interval 38.89 to 45.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12 post transplantPopulation: Full analysis set
Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Outcome measures
| Measure |
TAC+MPA
n=174 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=162 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=151 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant
|
60.26 mL/min per 1.73m²
Interval 55.85 to 64.68
|
52.25 mL/min per 1.73m²
Interval 47.88 to 56.61
|
51.30 mL/min per 1.73m²
Interval 46.85 to 55.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12 post transplantPopulation: Full analysis set
Modification of Diet in Renal Disease (MDRD) = For men: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x (albumin0,318) For women: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x albumin0,318) x 0.762 with urea nitrogen = urea / 2.144. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model
Outcome measures
| Measure |
TAC+MPA
n=172 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=156 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=140 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant
|
53.24 mL/min per 1.73m²
Interval 49.62 to 56.87
|
45.72 mL/min per 1.73m²
Interval 42.11 to 49.32
|
43.47 mL/min per 1.73m²
Interval 39.75 to 47.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12 post transplantTreatment failure endpoints: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)
Outcome measures
| Measure |
TAC+MPA
n=205 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=208 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=199 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Percentage of Participants With Treatment Failure Endpoints at Month 12
Graft loss
|
5.4 Percentage of participants
|
6.3 Percentage of participants
|
9.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment Failure Endpoints at Month 12
Death
|
4.9 Percentage of participants
|
6.3 Percentage of participants
|
6.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment Failure Endpoints at Month 12
Biopsy proven acute rejection (BPAR)
|
9.3 Percentage of participants
|
12.0 Percentage of participants
|
24.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment Failure Endpoints at Month 12
Treated BPAR (tBPAR)
|
8.8 Percentage of participants
|
11.5 Percentage of participants
|
23.6 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post transplant to month 12Population: Full analysis set
Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function (SGF) was defined as a serum creatinine \>3.0 mg/dL at Day 5 post-transplantation. Full analysis set
Outcome measures
| Measure |
TAC+MPA
n=205 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=208 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=199 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Percent of Participants With Delayed Graft Function and Slow Graft Function
Delayed graft function (197,187,172)
|
17.8 Percent of participants
|
20.3 Percent of participants
|
22.1 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function and Slow Graft Function
Slow graft function (195,187,171)
|
46.2 Percent of participants
|
48.7 Percent of participants
|
49.7 Percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post transplant up to day 7Population: Full analysis set
Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.
Outcome measures
| Measure |
TAC+MPA
n=35 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=38 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=38 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Percent of Participants With Delayed Graft Function by Day
day 7 (2,4,0)
|
5.7 Percent of participants
|
10.5 Percent of participants
|
0.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
>7 days (9,16,21)
|
25.7 Percent of participants
|
42.1 Percent of participants
|
55.3 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
day 1 (8,7,4)
|
22.9 Percent of participants
|
18.4 Percent of participants
|
10.5 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
day 2 (2,2,2)
|
5.7 Percent of participants
|
5.3 Percent of participants
|
5.3 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
day 3 (5,1,2)
|
14.3 Percent of participants
|
2.6 Percent of participants
|
5.3 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
day 4 (4,2,4)
|
11.4 Percent of participants
|
5.3 Percent of participants
|
10.5 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
day 5 (4,5,3)
|
11.4 Percent of participants
|
13.2 Percent of participants
|
7.9 Percent of participants
|
—
|
—
|
|
Percent of Participants With Delayed Graft Function by Day
day 6 (1,1,2)
|
2.9 Percent of participants
|
2.6 Percent of participants
|
5.3 Percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post transplant to month 12Population: Safety set
Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus
Outcome measures
| Measure |
TAC+MPA
n=204 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=210 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=198 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Percent of Participants With Viral Infections
Viral infections - CMVMissing
|
1.0 Percent of participants
|
0.0 Percent of participants
|
1.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - CMVModerate
|
6.0 Percent of participants
|
1.0 Percent of participants
|
1.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - CMVSevere
|
1.0 Percent of participants
|
0.0 Percent of participants
|
0.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - BKVAsymptomatic
|
10.0 Percent of participants
|
8.0 Percent of participants
|
5.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - BKVMild
|
5.0 Percent of participants
|
7.0 Percent of participants
|
3.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - CMVAsymptomatic
|
7.0 Percent of participants
|
1.0 Percent of participants
|
1.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - CMVMild
|
5.0 Percent of participants
|
2.0 Percent of participants
|
1.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - BKVModerate
|
7.0 Percent of participants
|
2.0 Percent of participants
|
1.0 Percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Infections
Viral infections - BKVSevere
|
0 Percent of participants
|
0 Percent of participants
|
0 Percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post transplant until individual reportingInformation collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles
Outcome measures
| Measure |
TAC+MPA
n=204 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=210 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=198 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Percent of Participants With Wound Healing Complications During Study
Wound healing complication
|
14.3 Percent of participants
|
19.1 Percent of participants
|
22.2 Percent of participants
|
—
|
—
|
|
Percent of Participants With Wound Healing Complications During Study
Fluids detected
|
18.7 Percent of participants
|
26.8 Percent of participants
|
27.8 Percent of participants
|
—
|
—
|
|
Percent of Participants With Wound Healing Complications During Study
Occurrence of lymphoceles
|
11.8 Percent of participants
|
18.2 Percent of participants
|
21.8 Percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post transplant until individual reportingA wound will be considered healed if all the suture material and staples are removed and the wound is intact. Number of participants is based on all patients of the respective treatment group in the safety set, excluding patients with no answer (unknown).
Outcome measures
| Measure |
TAC+MPA
n=28 Participants
Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
|
TAC+Certican
n=34 Participants
Tacrolimus, Certican, corticosteroids and Simulect
|
CycA+Certican
n=38 Participants
Cyclosporin A, Certican, corticosteroids and Simulect
|
Tac+Certican - Tac+MPA - Difference Between Groups
|
CycA+Certican -Tac+MPA - Difference Between Groups
|
|---|---|---|---|---|---|
|
Duration of Wound Healing
|
42.4 days
Standard Deviation 41.13
|
54.1 days
Standard Deviation 61.97
|
85.3 days
Standard Deviation 62.7
|
—
|
—
|
Adverse Events
Tac+MPA
Serious events: 135 serious events
Other events: 200 other events
Deaths: 0 deaths
Tac+Certican
Serious events: 161 serious events
Other events: 205 other events
Deaths: 0 deaths
CycA+Certican
Serious events: 144 serious events
Other events: 196 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tac+MPA
n=204 participants at risk
Tac+MPA
|
Tac+Certican
n=210 participants at risk
Tac+Certican
|
CycA+Certican
n=198 participants at risk
CycA+Certican
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.5%
5/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Acute myocardial infarction
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Cardiac failure
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Cardiac flutter
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Cardiovascular disorder
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Coronary artery disease
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Intracardiac thrombus
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Long QT syndrome
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Mitral valve disease
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Congenital, familial and genetic disorders
Abdominal wall anomaly
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Endocrine disorders
Parathyroid gland enlargement
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Eye disorders
Eyelid oedema
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Eye disorders
Retinal detachment
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal distension
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Anal sphincter atony
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
General disorders
Asthenia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
General disorders
Drug intolerance
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
General disorders
General physical health deterioration
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
General disorders
Hyperthermia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
General disorders
Impaired healing
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
General disorders
Incarcerated hernia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
General disorders
Inflammation
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
General disorders
Malaise
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
General disorders
Oedema
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
General disorders
Oedema peripheral
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
1.9%
4/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
General disorders
Pain
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
General disorders
Peripheral swelling
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
General disorders
Pyrexia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Anaphylactic reaction
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Chronic allograft nephropathy
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Kidney transplant rejection
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
9.0%
19/210 • Timeframe for AE
AE additional description
|
11.1%
22/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Renal transplant failure
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
4.3%
9/210 • Timeframe for AE
AE additional description
|
5.6%
11/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Transplant rejection
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
8.6%
17/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Abdominal abscess
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
BK virus infection
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Bronchitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Clostridium difficile colitis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Cytomegalovirus infection
|
5.4%
11/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Device related infection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Diarrhoea infectious
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
2.9%
6/210 • Timeframe for AE
AE additional description
|
3.0%
6/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Epididymitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Erysipelas
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Escherichia sepsis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Febrile infection
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Gastroenteritis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Graft infection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
1.9%
4/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Herpes zoster
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Infected lymphocele
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Infection
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
2.5%
5/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Influenza
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Kidney infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Localised infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Lung infection
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Mastitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Myocarditis infectious
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Orchitis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Peritonitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pneumonia
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
4.8%
10/210 • Timeframe for AE
AE additional description
|
4.0%
8/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pyelonephritis
|
4.9%
10/204 • Timeframe for AE
AE additional description
|
4.3%
9/210 • Timeframe for AE
AE additional description
|
4.0%
8/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Renal abscess
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Renal cyst infection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Respiratory tract infection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Sepsis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Septic shock
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Shunt infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Sinusitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Skin infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Ureteritis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
10.3%
21/204 • Timeframe for AE
AE additional description
|
12.9%
27/210 • Timeframe for AE
AE additional description
|
8.1%
16/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Urosepsis
|
4.4%
9/204 • Timeframe for AE
AE additional description
|
2.9%
6/210 • Timeframe for AE
AE additional description
|
3.5%
7/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Varicella zoster virus infection
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Wound infection
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
8.8%
18/204 • Timeframe for AE
AE additional description
|
10.5%
22/210 • Timeframe for AE
AE additional description
|
9.1%
18/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Kidney rupture
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Shunt blood flow excessive
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Investigations
Blood creatine increased
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
Blood creatinine increased
|
5.4%
11/204 • Timeframe for AE
AE additional description
|
9.5%
20/210 • Timeframe for AE
AE additional description
|
9.6%
19/198 • Timeframe for AE
AE additional description
|
|
Investigations
C-reactive protein increased
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
Cardiac monitoring
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Investigations
Creatinine renal clearance decreased
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Investigations
Epstein-Barr virus antigen positive
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
General physical condition abnormal
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Investigations
Weight decreased
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Dehydration
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
5/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell unclassifiable lymphoma high grade
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac valve fibroelastoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marrow hyperplasia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous adenocarcinoma of appendix
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Balance disorder
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Transient ischaemic attack
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Product Issues
Device leakage
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Product Issues
Device occlusion
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Confusional state
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Depression
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Depressive symptom
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Acute kidney injury
|
4.4%
9/204 • Timeframe for AE
AE additional description
|
5.7%
12/210 • Timeframe for AE
AE additional description
|
3.5%
7/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Hydronephrosis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
1.9%
4/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Micturition disorder
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Nephrocalcinosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Postrenal failure
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal artery dissection
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal failure
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal impairment
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
3.8%
8/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal infarct
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Urethral stenosis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Urinary fistula
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Urinoma
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.0%
2/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal cyst
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
2.5%
5/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Surgical and medical procedures
Renal transplant
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
2.5%
5/198 • Timeframe for AE
AE additional description
|
|
Surgical and medical procedures
Steroid therapy
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Surgical and medical procedures
Vascular anastomosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Arteriovenous fistula
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Deep vein thrombosis
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Haematoma
|
2.5%
5/204 • Timeframe for AE
AE additional description
|
4.3%
9/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
1.4%
3/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Hypertension
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.95%
2/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Hypertensive crisis
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Hypotension
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Lymphocele
|
5.9%
12/204 • Timeframe for AE
AE additional description
|
9.0%
19/210 • Timeframe for AE
AE additional description
|
12.1%
24/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Lymphorrhoea
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Peripheral artery stenosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Phlebitis deep
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Thrombosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.48%
1/210 • Timeframe for AE
AE additional description
|
0.00%
0/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Venous thrombosis
|
0.49%
1/204 • Timeframe for AE
AE additional description
|
0.00%
0/210 • Timeframe for AE
AE additional description
|
0.51%
1/198 • Timeframe for AE
AE additional description
|
Other adverse events
| Measure |
Tac+MPA
n=204 participants at risk
Tac+MPA
|
Tac+Certican
n=210 participants at risk
Tac+Certican
|
CycA+Certican
n=198 participants at risk
CycA+Certican
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.6%
44/204 • Timeframe for AE
AE additional description
|
25.2%
53/210 • Timeframe for AE
AE additional description
|
29.3%
58/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
34/204 • Timeframe for AE
AE additional description
|
8.1%
17/210 • Timeframe for AE
AE additional description
|
5.6%
11/198 • Timeframe for AE
AE additional description
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
9.5%
20/210 • Timeframe for AE
AE additional description
|
10.1%
20/198 • Timeframe for AE
AE additional description
|
|
Cardiac disorders
Tachycardia
|
6.9%
14/204 • Timeframe for AE
AE additional description
|
4.8%
10/210 • Timeframe for AE
AE additional description
|
5.1%
10/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
16/204 • Timeframe for AE
AE additional description
|
8.6%
18/210 • Timeframe for AE
AE additional description
|
9.1%
18/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.9%
14/204 • Timeframe for AE
AE additional description
|
9.0%
19/210 • Timeframe for AE
AE additional description
|
6.1%
12/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
34.8%
71/204 • Timeframe for AE
AE additional description
|
32.9%
69/210 • Timeframe for AE
AE additional description
|
40.9%
81/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
19/204 • Timeframe for AE
AE additional description
|
8.1%
17/210 • Timeframe for AE
AE additional description
|
3.0%
6/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
14/204 • Timeframe for AE
AE additional description
|
8.1%
17/210 • Timeframe for AE
AE additional description
|
4.5%
9/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Flatulence
|
11.8%
24/204 • Timeframe for AE
AE additional description
|
16.7%
35/210 • Timeframe for AE
AE additional description
|
12.6%
25/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
22.5%
46/204 • Timeframe for AE
AE additional description
|
21.0%
44/210 • Timeframe for AE
AE additional description
|
21.2%
42/198 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
27/204 • Timeframe for AE
AE additional description
|
10.5%
22/210 • Timeframe for AE
AE additional description
|
11.1%
22/198 • Timeframe for AE
AE additional description
|
|
General disorders
Impaired healing
|
2.5%
5/204 • Timeframe for AE
AE additional description
|
6.2%
13/210 • Timeframe for AE
AE additional description
|
7.6%
15/198 • Timeframe for AE
AE additional description
|
|
General disorders
Oedema
|
5.4%
11/204 • Timeframe for AE
AE additional description
|
4.3%
9/210 • Timeframe for AE
AE additional description
|
4.0%
8/198 • Timeframe for AE
AE additional description
|
|
General disorders
Oedema peripheral
|
30.4%
62/204 • Timeframe for AE
AE additional description
|
39.0%
82/210 • Timeframe for AE
AE additional description
|
50.0%
99/198 • Timeframe for AE
AE additional description
|
|
Immune system disorders
Kidney transplant rejection
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
4.3%
9/210 • Timeframe for AE
AE additional description
|
7.1%
14/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
BK virus infection
|
22.1%
45/204 • Timeframe for AE
AE additional description
|
17.1%
36/210 • Timeframe for AE
AE additional description
|
9.1%
18/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Bronchitis
|
6.4%
13/204 • Timeframe for AE
AE additional description
|
2.4%
5/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Cytomegalovirus infection
|
16.2%
33/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
1.5%
3/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Diarrhoea infectious
|
27.5%
56/204 • Timeframe for AE
AE additional description
|
19.0%
40/210 • Timeframe for AE
AE additional description
|
14.6%
29/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
14.2%
29/204 • Timeframe for AE
AE additional description
|
14.8%
31/210 • Timeframe for AE
AE additional description
|
10.6%
21/198 • Timeframe for AE
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
39.7%
81/204 • Timeframe for AE
AE additional description
|
35.2%
74/210 • Timeframe for AE
AE additional description
|
36.4%
72/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
13.7%
28/204 • Timeframe for AE
AE additional description
|
17.1%
36/210 • Timeframe for AE
AE additional description
|
21.7%
43/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.7%
26/204 • Timeframe for AE
AE additional description
|
11.9%
25/210 • Timeframe for AE
AE additional description
|
10.6%
21/198 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
Wound complication
|
33.3%
68/204 • Timeframe for AE
AE additional description
|
30.5%
64/210 • Timeframe for AE
AE additional description
|
28.3%
56/198 • Timeframe for AE
AE additional description
|
|
Investigations
Blood creatinine increased
|
12.3%
25/204 • Timeframe for AE
AE additional description
|
12.9%
27/210 • Timeframe for AE
AE additional description
|
13.1%
26/198 • Timeframe for AE
AE additional description
|
|
Investigations
Blood glucose increased
|
2.9%
6/204 • Timeframe for AE
AE additional description
|
7.1%
15/210 • Timeframe for AE
AE additional description
|
4.0%
8/198 • Timeframe for AE
AE additional description
|
|
Investigations
C-reactive protein increased
|
4.4%
9/204 • Timeframe for AE
AE additional description
|
7.1%
15/210 • Timeframe for AE
AE additional description
|
6.6%
13/198 • Timeframe for AE
AE additional description
|
|
Investigations
Haemoglobin decreased
|
4.4%
9/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
4.5%
9/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.8%
24/204 • Timeframe for AE
AE additional description
|
15.7%
33/210 • Timeframe for AE
AE additional description
|
12.1%
24/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.98%
2/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
3.5%
7/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.4%
7/204 • Timeframe for AE
AE additional description
|
3.3%
7/210 • Timeframe for AE
AE additional description
|
6.6%
13/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.8%
16/204 • Timeframe for AE
AE additional description
|
7.6%
16/210 • Timeframe for AE
AE additional description
|
6.6%
13/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.5%
5/204 • Timeframe for AE
AE additional description
|
7.6%
16/210 • Timeframe for AE
AE additional description
|
8.6%
17/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
12/204 • Timeframe for AE
AE additional description
|
9.5%
20/210 • Timeframe for AE
AE additional description
|
12.6%
25/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
31.9%
65/204 • Timeframe for AE
AE additional description
|
25.2%
53/210 • Timeframe for AE
AE additional description
|
29.3%
58/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
6.2%
13/210 • Timeframe for AE
AE additional description
|
11.6%
23/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.5%
5/204 • Timeframe for AE
AE additional description
|
3.3%
7/210 • Timeframe for AE
AE additional description
|
6.1%
12/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
6.2%
13/210 • Timeframe for AE
AE additional description
|
5.1%
10/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.8%
20/204 • Timeframe for AE
AE additional description
|
4.8%
10/210 • Timeframe for AE
AE additional description
|
7.1%
14/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.8%
20/204 • Timeframe for AE
AE additional description
|
12.9%
27/210 • Timeframe for AE
AE additional description
|
8.6%
17/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.2%
33/204 • Timeframe for AE
AE additional description
|
17.6%
37/210 • Timeframe for AE
AE additional description
|
20.7%
41/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.3%
23/204 • Timeframe for AE
AE additional description
|
17.1%
36/210 • Timeframe for AE
AE additional description
|
15.2%
30/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.9%
6/204 • Timeframe for AE
AE additional description
|
3.8%
8/210 • Timeframe for AE
AE additional description
|
5.1%
10/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
11.8%
24/204 • Timeframe for AE
AE additional description
|
11.9%
25/210 • Timeframe for AE
AE additional description
|
10.6%
21/198 • Timeframe for AE
AE additional description
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.3%
21/204 • Timeframe for AE
AE additional description
|
9.5%
20/210 • Timeframe for AE
AE additional description
|
7.1%
14/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
4/204 • Timeframe for AE
AE additional description
|
3.3%
7/210 • Timeframe for AE
AE additional description
|
5.6%
11/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
17/204 • Timeframe for AE
AE additional description
|
7.6%
16/210 • Timeframe for AE
AE additional description
|
5.1%
10/198 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.4%
9/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
3.5%
7/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Headache
|
7.4%
15/204 • Timeframe for AE
AE additional description
|
11.9%
25/210 • Timeframe for AE
AE additional description
|
7.6%
15/198 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
Tremor
|
14.7%
30/204 • Timeframe for AE
AE additional description
|
10.5%
22/210 • Timeframe for AE
AE additional description
|
4.5%
9/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Anxiety
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
7.1%
15/210 • Timeframe for AE
AE additional description
|
4.5%
9/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Insomnia
|
20.1%
41/204 • Timeframe for AE
AE additional description
|
18.6%
39/210 • Timeframe for AE
AE additional description
|
12.1%
24/198 • Timeframe for AE
AE additional description
|
|
Psychiatric disorders
Sleep disorder
|
10.8%
22/204 • Timeframe for AE
AE additional description
|
10.0%
21/210 • Timeframe for AE
AE additional description
|
11.1%
22/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Dysuria
|
6.9%
14/204 • Timeframe for AE
AE additional description
|
6.7%
14/210 • Timeframe for AE
AE additional description
|
7.1%
14/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Haematuria
|
6.9%
14/204 • Timeframe for AE
AE additional description
|
9.0%
19/210 • Timeframe for AE
AE additional description
|
6.6%
13/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Leukocyturia
|
6.9%
14/204 • Timeframe for AE
AE additional description
|
6.2%
13/210 • Timeframe for AE
AE additional description
|
4.0%
8/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Nocturia
|
5.9%
12/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
7.1%
14/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Pollakiuria
|
4.4%
9/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
4.5%
9/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Proteinuria
|
11.8%
24/204 • Timeframe for AE
AE additional description
|
12.4%
26/210 • Timeframe for AE
AE additional description
|
15.2%
30/198 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
Renal impairment
|
7.4%
15/204 • Timeframe for AE
AE additional description
|
6.2%
13/210 • Timeframe for AE
AE additional description
|
4.0%
8/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
11/204 • Timeframe for AE
AE additional description
|
7.1%
15/210 • Timeframe for AE
AE additional description
|
7.1%
14/198 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
21/204 • Timeframe for AE
AE additional description
|
10.5%
22/210 • Timeframe for AE
AE additional description
|
9.6%
19/198 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.5%
3/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
2.0%
4/198 • Timeframe for AE
AE additional description
|
|
Surgical and medical procedures
Renal transplant
|
3.9%
8/204 • Timeframe for AE
AE additional description
|
4.3%
9/210 • Timeframe for AE
AE additional description
|
8.6%
17/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Haematoma
|
4.9%
10/204 • Timeframe for AE
AE additional description
|
7.6%
16/210 • Timeframe for AE
AE additional description
|
8.6%
17/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Hypertension
|
25.5%
52/204 • Timeframe for AE
AE additional description
|
29.5%
62/210 • Timeframe for AE
AE additional description
|
28.8%
57/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Hypotension
|
6.4%
13/204 • Timeframe for AE
AE additional description
|
5.2%
11/210 • Timeframe for AE
AE additional description
|
8.1%
16/198 • Timeframe for AE
AE additional description
|
|
Vascular disorders
Lymphocele
|
9.8%
20/204 • Timeframe for AE
AE additional description
|
10.5%
22/210 • Timeframe for AE
AE additional description
|
15.7%
31/198 • Timeframe for AE
AE additional description
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-779-8300
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trail results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigation from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER