Trial Outcomes & Findings for Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients (NCT NCT00064701)
NCT ID: NCT00064701
Last Updated: 2013-12-05
Results Overview
Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis \[\> 30 days\] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
668 participants
Primary outcome timeframe
one year
Results posted on
2013-12-05
Participant Flow
De novo kidney transplant recipients 12 years of age and older were randomized in a 1:1:1 ratio to 1 of 3 treatment arms.
This study was a 1-year safety and efficacy study followed by a clinical continuation phase that continued until the sponsor discontinued the study in March 2009.
Participant milestones
| Measure |
Tacrolimus
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
One Year Post-transplant
STARTED
|
219
|
226
|
223
|
|
One Year Post-transplant
Received Study Drug
|
212
|
214
|
212
|
|
One Year Post-transplant
COMPLETED
|
179
|
183
|
151
|
|
One Year Post-transplant
NOT COMPLETED
|
40
|
43
|
72
|
|
Clinical Continuation Phase
STARTED
|
179
|
182
|
151
|
|
Clinical Continuation Phase
COMPLETED
|
9
|
4
|
11
|
|
Clinical Continuation Phase
NOT COMPLETED
|
170
|
178
|
140
|
Reasons for withdrawal
| Measure |
Tacrolimus
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
One Year Post-transplant
Did not receive study drug
|
7
|
12
|
11
|
|
One Year Post-transplant
Adverse Event
|
23
|
19
|
37
|
|
One Year Post-transplant
Rejection
|
0
|
1
|
16
|
|
One Year Post-transplant
Non-compliance
|
4
|
2
|
5
|
|
One Year Post-transplant
Graft Failure
|
3
|
2
|
1
|
|
One Year Post-transplant
Withdrawal by Subject
|
0
|
4
|
1
|
|
One Year Post-transplant
Lost to Follow-up
|
1
|
0
|
0
|
|
One Year Post-transplant
Converted to rapamycin
|
1
|
0
|
0
|
|
One Year Post-transplant
Acute tubular necrosis
|
1
|
0
|
0
|
|
One Year Post-transplant
Incorrect study drug dispensed
|
0
|
1
|
0
|
|
One Year Post-transplant
Crossover secondary to possible toxicity
|
0
|
1
|
0
|
|
One Year Post-transplant
Poor absorption
|
0
|
1
|
0
|
|
One Year Post-transplant
Pancreas transplant
|
0
|
0
|
1
|
|
Clinical Continuation Phase
Adverse Event
|
12
|
21
|
14
|
|
Clinical Continuation Phase
Non-compliance
|
8
|
6
|
7
|
|
Clinical Continuation Phase
Withdrawal by Subject
|
22
|
3
|
22
|
|
Clinical Continuation Phase
Lost to Follow-up
|
6
|
3
|
6
|
|
Clinical Continuation Phase
Graft Failure
|
5
|
5
|
2
|
|
Clinical Continuation Phase
Rejection
|
1
|
2
|
2
|
|
Clinical Continuation Phase
Sponsor discontinued study
|
113
|
129
|
79
|
|
Clinical Continuation Phase
Immunosuppressive treatment crossover
|
0
|
3
|
6
|
|
Clinical Continuation Phase
Physician Decision
|
1
|
3
|
0
|
|
Clinical Continuation Phase
Unable to return to site for study visit
|
1
|
0
|
1
|
|
Clinical Continuation Phase
Pancreas transplant
|
1
|
0
|
0
|
|
Clinical Continuation Phase
Ran out of study drug due to Hurricane
|
0
|
1
|
0
|
|
Clinical Continuation Phase
Discharged to nursing home
|
0
|
1
|
0
|
|
Clinical Continuation Phase
Incorrect study drug dispensed
|
0
|
1
|
0
|
|
Clinical Continuation Phase
Patient opted out
|
0
|
0
|
1
|
Baseline Characteristics
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Total
n=638 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
48.62 years
STANDARD_DEVIATION 12.855 • n=93 Participants
|
47.84 years
STANDARD_DEVIATION 12.995 • n=4 Participants
|
47.63 years
STANDARD_DEVIATION 12.953 • n=27 Participants
|
48.03 years
STANDARD_DEVIATION 12.921 • n=483 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
234 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=93 Participants
|
138 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
404 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
152 participants
n=93 Participants
|
160 participants
n=4 Participants
|
163 participants
n=27 Participants
|
475 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black
|
51 participants
n=93 Participants
|
41 participants
n=4 Participants
|
36 participants
n=27 Participants
|
128 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
18 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=93 Participants
|
8 participants
n=4 Participants
|
5 participants
n=27 Participants
|
17 participants
n=483 Participants
|
|
Primary Diagnosis
Nephrosclerosis/ Hypertensive Nephropathy
|
54 participants
n=93 Participants
|
56 participants
n=4 Participants
|
43 participants
n=27 Participants
|
153 participants
n=483 Participants
|
|
Primary Diagnosis
Diabetic Nephropathy
|
46 participants
n=93 Participants
|
38 participants
n=4 Participants
|
46 participants
n=27 Participants
|
130 participants
n=483 Participants
|
|
Primary Diagnosis
Glomerulonephritis
|
44 participants
n=93 Participants
|
43 participants
n=4 Participants
|
43 participants
n=27 Participants
|
130 participants
n=483 Participants
|
|
Primary Diagnosis
Polycycstic Kidney Disease
|
20 participants
n=93 Participants
|
26 participants
n=4 Participants
|
20 participants
n=27 Participants
|
66 participants
n=483 Participants
|
|
Primary Diagnosis
Tubular/ Interstitial Disease
|
9 participants
n=93 Participants
|
5 participants
n=4 Participants
|
16 participants
n=27 Participants
|
30 participants
n=483 Participants
|
|
Primary Diagnosis
Systemic Vasculitis
|
9 participants
n=93 Participants
|
10 participants
n=4 Participants
|
7 participants
n=27 Participants
|
26 participants
n=483 Participants
|
|
Primary Diagnosis
Congenital/ Hereditary Nephropathy
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
13 participants
n=27 Participants
|
27 participants
n=483 Participants
|
|
Primary Diagnosis
Reflux
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Primary Diagnosis
Unknown
|
17 participants
n=93 Participants
|
24 participants
n=4 Participants
|
17 participants
n=27 Participants
|
58 participants
n=483 Participants
|
|
Primary Diagnosis
Other
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
16 participants
n=483 Participants
|
|
Previous Transplant
No
|
205 participants
n=93 Participants
|
206 participants
n=4 Participants
|
203 participants
n=27 Participants
|
614 participants
n=483 Participants
|
|
Previous Transplant
Yes
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
9 participants
n=27 Participants
|
24 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set, defined as all randomized patients who received at least one dose of study drug.
Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis \[\> 30 days\] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Percentage of Participants With Efficacy Failure
|
15.1 percentage of participants
|
14.0 percentage of participants
|
17.0 percentage of participants
|
SECONDARY outcome
Timeframe: One yearPopulation: The number of participants analyzed represents the full analysis set.
Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Patient Survival at One Year
|
93.9 percentage of participants
|
97.2 percentage of participants
|
97.2 percentage of participants
|
SECONDARY outcome
Timeframe: One yearPopulation: The number of participants analyzed represents the full analysis set.
Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (\> 30 days), patient death, or participant whose outcome at one year was unknown. Participants were only counted once regardless of how many criteria were met.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Graft Survival at One Year
|
91.5 percentage of participants
|
95.3 percentage of participants
|
95.3 percentage of participants
|
SECONDARY outcome
Timeframe: Six months and 12 monthsPopulation: The number of participants analyzed represents the full analysis set.
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. Acute rejection is defined as a grade ≥ I.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months
At 6 Months
|
3.8 percentage of participants
|
7.9 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months
At 12 Months
|
7.5 percentage of participants
|
10.3 percentage of participants
|
13.7 percentage of participants
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set.
Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. Acute rejection is defined as a grade ≥ I.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Time to First Biopsy-confirmed Acute Rejection Episode
|
156.00 days
Interval 3.0 to 316.0
|
11.00 days
Interval 6.0 to 327.0
|
52.00 days
Interval 1.0 to 311.0
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set.
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection
|
6 participants
|
8 participants
|
18 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set with a biopsy-confirmed acute rejection episode during one year.
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising \>25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Outcome measures
| Measure |
Tacrolimus
n=16 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=22 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=29 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Severity of Acute Rejection
Grade I-A
|
8 participants
|
11 participants
|
14 participants
|
|
Severity of Acute Rejection
Grade I-B
|
4 participants
|
3 participants
|
6 participants
|
|
Severity of Acute Rejection
Grade II-A
|
3 participants
|
6 participants
|
6 participants
|
|
Severity of Acute Rejection
Grade II-B
|
1 participants
|
1 participants
|
1 participants
|
|
Severity of Acute Rejection
Grade III
|
0 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set.
This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Number of Participants Experiencing Multiple Rejection Episodes
|
2 participants
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set.
A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Number of Participants With Clinically Treated Acute Rejection Episodes
|
25 participants
|
39 participants
|
45 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set.
Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Number of Participants With Treatment Failure
|
33 participants
|
31 participants
|
61 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: The number of participants analyzed represents the full analysis set.
Participants were allowed to cross over to an alternative primary immunosuppressive regimen (either to the tacrolimus or cyclosporine treatment arms) to address an adverse event which led to randomized study drug discontinuation or in the case of severe or refractory rejection. Crossover to the modified release tacrolimus treatment arm was not permitted.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Number of Participants Who Crossed Over Due to Treatment Failure
|
6 participants
|
10 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Month 1, Month 6, and Month 12Population: The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.
Renal function was assessed by the change from Month 1 in serum creatinine six months and 12 months after transplant.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Change From Month 1 in Serum Creatinine at Month 6 and Month 12
At 6 months [N=184, 184, 169]
|
-0.09 mg/dL
Standard Deviation 0.63
|
-0.08 mg/dL
Standard Deviation 0.56
|
-0.01 mg/dL
Standard Deviation 0.53
|
|
Change From Month 1 in Serum Creatinine at Month 6 and Month 12
At 12 months [N=173, 182, 147]
|
-0.08 mg/dL
Standard Deviation 0.76
|
-0.14 mg/dL
Standard Deviation 0.62
|
-0.04 mg/dL
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Month 1, Month 6, and Month 12Population: The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.
Renal function was assessed by creatinine clearance, calculated using the Cockcroft-Gault formula.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Change From Month 1 in Creatinine Clearance at Month 6 and Month 12
At 6 months [N=184, 184, 167]
|
0.83 mL/min
Standard Deviation 13.77
|
0.47 mL/min
Standard Deviation 12.90
|
-1.79 mL/min
Standard Deviation 14.09
|
|
Change From Month 1 in Creatinine Clearance at Month 6 and Month 12
At 12 months [N=173, 182, 145]
|
1.50 mL/min
Standard Deviation 16.07
|
2.62 mL/min
Standard Deviation 14.32
|
-0.25 mL/min
Standard Deviation 14.54
|
SECONDARY outcome
Timeframe: End of study (maximum time on study was 1,941 days).Population: The number of participants analyzed represents the full analysis set.
Patient survival was defined as any participant who was alive at the end of the study. Patient survival was censored at the time of last follow-up contact.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Patient Survival at the End of the Study
|
91.2 percentage of participants
Interval 86.8 to 95.7
|
93.2 percentage of participants
Interval 89.7 to 96.8
|
91.7 percentage of participants
Interval 87.7 to 95.8
|
SECONDARY outcome
Timeframe: End of study (maximum time on study was 1,941 days).Population: The number of participants analyzed represents the full analysis set.
Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was any retransplant or the permanent return to dialysis (more than 30 days) or patient death. Graft survival was censored at the time of last follow-up contact.
Outcome measures
| Measure |
Tacrolimus
n=212 Participants
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 Participants
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 Participants
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Graft Survival at the End of the Study
|
82.7 percentage of participants
Interval 76.9 to 88.4
|
84.7 percentage of participants
Interval 79.0 to 90.4
|
83.9 percentage of participants
Interval 78.6 to 89.3
|
Adverse Events
Tacrolimus
Serious events: 148 serious events
Other events: 208 other events
Deaths: 0 deaths
Tacrolimus Modified Release
Serious events: 141 serious events
Other events: 212 other events
Deaths: 0 deaths
Cyclosporine
Serious events: 139 serious events
Other events: 208 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tacrolimus
n=212 participants at risk
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 participants at risk
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 participants at risk
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Monoarthritis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Bone Spur
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Cytomegalovirus infection
|
7.1%
15/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
5.2%
11/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection
|
7.1%
15/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
7.1%
15/212 • Up to 1941 days
|
|
Infections and infestations
Human polyomavirus infection
|
4.2%
9/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Sepsis
|
2.8%
6/212 • Up to 1941 days
|
3.7%
8/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Infections and infestations
Gastroenteritis viral
|
2.4%
5/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Urosepsis
|
2.4%
5/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Infections and infestations
Cellulitis
|
1.9%
4/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Infections and infestations
Gastroenteritis
|
1.9%
4/212 • Up to 1941 days
|
6.5%
14/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Infections and infestations
Pneumonia
|
1.9%
4/212 • Up to 1941 days
|
4.7%
10/214 • Up to 1941 days
|
3.3%
7/212 • Up to 1941 days
|
|
Infections and infestations
Pyelonephritis
|
1.9%
4/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Infections and infestations
Bronchitis
|
1.4%
3/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.4%
3/212 • Up to 1941 days
|
2.8%
6/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Infections and infestations
Herpes zoster
|
1.4%
3/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Strongyloidiasis
|
1.4%
3/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.4%
3/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Infections and infestations
Bacteraemia
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Endocarditis
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Osteomyelitis
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Subcutaneous abscess
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Abdominal abscess
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Abscess
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Abscess limb
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Bronchitis acute
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Bronchopneumonia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Catheter related infection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Catheter sepsis
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Clostridial infection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Clostridium colitis
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Diabetic foot infection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Infections and infestations
Diarrhoea infectious
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Escherichia bacteraemia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Furuncle
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Infected cyst
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Infected skin ulcer
|
0.47%
1/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Lobar pneumonia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Localised infection
|
0.47%
1/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Lung infection pseudomonal
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Mastoiditis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Orchitis
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Otitis media
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Pharyngotonsillitis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Pneumonia fungal
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Infections and infestations
Skin bacterial infection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Staphylococcal infection
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Streptococcal sepsis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Tracheobronchitis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Tuberculosis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection fungal
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Vancomycin resistant enterococcal infection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Viral infection
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Vulval abscess
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Wound infection
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Appendicitis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Choriomeningitis lymphocytic
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Condyloma acuminatum
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Cytomegalovirus gastritis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Gastritis fungal
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Groin infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Herpetic gingivostomatitis infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Influenza
|
0.00%
0/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Meningitits aseptic
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Meningitits cryptococcal
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Postoperative infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Vaginitis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Infections and infestations
Varicella
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
12/212 • Up to 1941 days
|
4.7%
10/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
8/212 • Up to 1941 days
|
3.7%
8/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Nausea
|
3.3%
7/212 • Up to 1941 days
|
2.8%
6/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
5/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
5/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Diverticulitis
|
0.94%
2/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal wall cyst
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Ascites
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Diarhoea haemorrhagic
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Faecaloma
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastritis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Pancreatitis due to biliary obstruction
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Rectal polyp
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Subileus
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Umbilical hernia obstructive
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal haematoma
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal wall disorder
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastric ulcer haemorhage
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Oesophageal erosion
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
2.4%
5/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
2.4%
5/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
2.4%
5/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site complication
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Postoperative haematoma
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Medical device compilation
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
9/212 • Up to 1941 days
|
4.7%
10/214 • Up to 1941 days
|
2.8%
6/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
5/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
5/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.9%
4/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.94%
2/212 • Up to 1941 days
|
2.8%
6/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.47%
1/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Gout
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Investigations
Blood creatinine increased
|
8.5%
18/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
7.1%
15/212 • Up to 1941 days
|
|
Investigations
Blood in stool
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Blood urea increased
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Cardiac stress test abnormal
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Investigations
Haematocrit decreased
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Haemaglobin decreased
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Hepatic enzyme increased
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Volume blood decreased
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Blood creatine increased
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Investigations
Blood glucose increased
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Investigations
International normalized ration increased
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Investigations
Urine output decreased
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Investigations
Weight decreased
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal failure acute
|
4.2%
9/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
3.3%
7/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal Impairment
|
1.9%
4/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
3/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Renal and urinary disorders
Dysuria
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Renal and urinary disorders
Haematuria
|
0.94%
2/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal insufficiency
|
0.94%
2/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Bladder disorder
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Nephropathy
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Urinary retention
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Nephropathy Toxic
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Stress incontinence
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
5/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
4/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Angina pectoris
|
1.4%
3/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
3/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
3/212 • Up to 1941 days
|
2.8%
6/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.94%
2/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Cardiac disorders
Cardiac failure
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Aortic valve incompetence
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Atrial flutter
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Pericarditis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Right ventricular failure
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Cardio respiratory arrest
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Ventricular bigeminy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
7/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Vascular disorders
Haematoma
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Vascular disorders
Hypotension
|
0.94%
2/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Vascular disorders
Lymphocele
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Vascular disorders
Arterial thrombosis limb
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Arterivenous Fistula, acquired
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Gangrene
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Vascular disorders
Lymphorrhoea
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Vascular disorders
Peripheral artery dissection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Peripheral vascular disorder
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Thrombosis
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Vascular Insufficency
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Atherosclerosis
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Peripheral occlusive disease
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Vascular disorders
Renovascular Hypertension
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
6/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
2/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.94%
2/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory failure
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive airways Disease
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive airways Disease exacerbated
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Maxillary sinusitis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
6/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.94%
2/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
1.4%
3/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
General disorders
Pyrexia
|
2.4%
5/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
3.8%
8/212 • Up to 1941 days
|
|
General disorders
Chest pain
|
0.94%
2/212 • Up to 1941 days
|
1.9%
4/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Oedema peripheral
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Adhesion
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Asthenia
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
General disorders
Impaired healing
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Non-cardiac chest pain
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Systemic inflammatory response syndrome
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Anasarca
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Fatigue
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Oedema
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Rigors
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Sudden death
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
General disorders
Swelling
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Convulsion
|
1.4%
3/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Nervous system disorders
Dizziness
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Headache
|
0.94%
2/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Depressed level of consciousness
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Diabetic hypersmolar coma
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Dysaesthesia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Guillain Barre syndrome
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Sleep apnoea syndrome
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Sleep paralysis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Viith nerve paralysis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.9%
4/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.4%
3/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the pancreas
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.47%
1/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphooroliferative disorder
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Localized osteoarthritis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Spondylosis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Depression
|
1.4%
3/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Mental status changes
|
0.94%
2/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Psychotic disorder
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Major depression
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Epididymitis
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Testicular infarction
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Pelvic muscles inadequate
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Prostatis
|
0.00%
0/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Knee arthoplasty
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Nephrectomy
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Pancreas transplant
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Surgical and medical procedures
Abdominal panniculectomy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Abdominoplasty
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Colostomy closure
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Surgical and medical procedures
Small intestinal resection
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
1.4%
3/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Endocrine disorders
Goitre
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Endocrine disorders
Hyperparathyroidism
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Bile duct stone
|
0.94%
2/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/212 • Up to 1941 days
|
0.93%
2/214 • Up to 1941 days
|
0.94%
2/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/212 • Up to 1941 days
|
1.4%
3/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Immune system disorders
Graft loss
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Immune system disorders
Kidney transplant rejection
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
|
Congenital, familial and genetic disorders
Anomalous pulmonary venous connection
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Eye disorders
Retinitis
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.47%
1/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Social circumstances
Murder
|
0.47%
1/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Social circumstances
Treatment noncompliance
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/212 • Up to 1941 days
|
0.47%
1/214 • Up to 1941 days
|
0.00%
0/212 • Up to 1941 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
0.47%
1/212 • Up to 1941 days
|
Other adverse events
| Measure |
Tacrolimus
n=212 participants at risk
Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Tacrolimus Modified Release
n=214 participants at risk
Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
Cyclosporine
n=212 participants at risk
Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
91/212 • Up to 1941 days
|
43.9%
94/214 • Up to 1941 days
|
25.0%
53/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Constipation
|
32.1%
68/212 • Up to 1941 days
|
39.7%
85/214 • Up to 1941 days
|
38.7%
82/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Nausea
|
33.5%
71/212 • Up to 1941 days
|
34.6%
74/214 • Up to 1941 days
|
42.5%
90/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
49/212 • Up to 1941 days
|
23.8%
51/214 • Up to 1941 days
|
21.7%
46/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Dyspepsia
|
17.0%
36/212 • Up to 1941 days
|
15.0%
32/214 • Up to 1941 days
|
15.1%
32/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
22/212 • Up to 1941 days
|
12.1%
26/214 • Up to 1941 days
|
16.5%
35/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.9%
21/212 • Up to 1941 days
|
7.5%
16/214 • Up to 1941 days
|
8.5%
18/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Flatulence
|
10.4%
22/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
6.6%
14/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
15/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
8.5%
18/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Loose stools
|
6.6%
14/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.4%
5/212 • Up to 1941 days
|
4.2%
9/214 • Up to 1941 days
|
5.7%
12/212 • Up to 1941 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
5/212 • Up to 1941 days
|
5.6%
12/214 • Up to 1941 days
|
2.8%
6/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
27.8%
59/212 • Up to 1941 days
|
23.4%
50/214 • Up to 1941 days
|
21.2%
45/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
26.9%
57/212 • Up to 1941 days
|
24.3%
52/214 • Up to 1941 days
|
20.8%
44/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
22.6%
48/212 • Up to 1941 days
|
18.7%
40/214 • Up to 1941 days
|
17.9%
38/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.5%
35/212 • Up to 1941 days
|
16.4%
35/214 • Up to 1941 days
|
24.5%
52/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.5%
37/212 • Up to 1941 days
|
14.0%
30/214 • Up to 1941 days
|
13.2%
28/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.6%
31/212 • Up to 1941 days
|
14.5%
31/214 • Up to 1941 days
|
15.6%
33/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
9.4%
20/212 • Up to 1941 days
|
11.7%
25/214 • Up to 1941 days
|
4.2%
9/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
15/212 • Up to 1941 days
|
6.1%
13/214 • Up to 1941 days
|
11.8%
25/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.7%
12/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
5.2%
11/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.7%
10/212 • Up to 1941 days
|
3.7%
8/214 • Up to 1941 days
|
7.5%
16/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.6%
14/212 • Up to 1941 days
|
4.2%
9/214 • Up to 1941 days
|
4.2%
9/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
16/212 • Up to 1941 days
|
4.7%
10/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.9%
4/212 • Up to 1941 days
|
5.6%
12/214 • Up to 1941 days
|
2.8%
6/212 • Up to 1941 days
|
|
General disorders
Oedema peripheral
|
34.0%
72/212 • Up to 1941 days
|
35.0%
75/214 • Up to 1941 days
|
45.8%
97/212 • Up to 1941 days
|
|
General disorders
Fatigue
|
10.4%
22/212 • Up to 1941 days
|
15.0%
32/214 • Up to 1941 days
|
12.3%
26/212 • Up to 1941 days
|
|
General disorders
Oedema
|
12.7%
27/212 • Up to 1941 days
|
7.9%
17/214 • Up to 1941 days
|
11.8%
25/212 • Up to 1941 days
|
|
General disorders
Pyrexia
|
9.4%
20/212 • Up to 1941 days
|
9.8%
21/214 • Up to 1941 days
|
13.2%
28/212 • Up to 1941 days
|
|
General disorders
Asthenia
|
10.4%
22/212 • Up to 1941 days
|
7.5%
16/214 • Up to 1941 days
|
10.4%
22/212 • Up to 1941 days
|
|
General disorders
Chest pain
|
7.5%
16/212 • Up to 1941 days
|
8.9%
19/214 • Up to 1941 days
|
5.7%
12/212 • Up to 1941 days
|
|
General disorders
Pain
|
3.8%
8/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
6.6%
14/212 • Up to 1941 days
|
|
General disorders
Anasarca
|
3.8%
8/212 • Up to 1941 days
|
5.6%
12/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Nervous system disorders
Tremor
|
34.4%
73/212 • Up to 1941 days
|
35.0%
75/214 • Up to 1941 days
|
19.8%
42/212 • Up to 1941 days
|
|
Nervous system disorders
Headache
|
23.6%
50/212 • Up to 1941 days
|
21.0%
45/214 • Up to 1941 days
|
24.5%
52/212 • Up to 1941 days
|
|
Nervous system disorders
Dizziness
|
12.7%
27/212 • Up to 1941 days
|
9.8%
21/214 • Up to 1941 days
|
10.8%
23/212 • Up to 1941 days
|
|
Nervous system disorders
Paraesthesia
|
1.4%
3/212 • Up to 1941 days
|
5.6%
12/214 • Up to 1941 days
|
6.1%
13/212 • Up to 1941 days
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
5/212 • Up to 1941 days
|
3.7%
8/214 • Up to 1941 days
|
5.2%
11/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Incision site complication
|
21.7%
46/212 • Up to 1941 days
|
14.5%
31/214 • Up to 1941 days
|
19.8%
42/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
19.8%
42/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
17.5%
37/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
19.3%
41/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
14.6%
31/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
2.8%
6/212 • Up to 1941 days
|
4.7%
10/214 • Up to 1941 days
|
5.7%
12/212 • Up to 1941 days
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
5.2%
11/212 • Up to 1941 days
|
2.3%
5/214 • Up to 1941 days
|
4.7%
10/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Anaemia
|
27.8%
59/212 • Up to 1941 days
|
31.8%
68/214 • Up to 1941 days
|
25.9%
55/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.6%
33/212 • Up to 1941 days
|
16.4%
35/214 • Up to 1941 days
|
11.8%
25/212 • Up to 1941 days
|
|
Blood and lymphatic system disorders
Polycythaemia
|
6.1%
13/212 • Up to 1941 days
|
5.6%
12/214 • Up to 1941 days
|
4.2%
9/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.7%
27/212 • Up to 1941 days
|
15.0%
32/214 • Up to 1941 days
|
13.7%
29/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
26/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
13.2%
28/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.7%
27/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
12.3%
26/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
8.0%
17/212 • Up to 1941 days
|
9.3%
20/214 • Up to 1941 days
|
10.4%
22/212 • Up to 1941 days
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.7%
12/212 • Up to 1941 days
|
6.1%
13/214 • Up to 1941 days
|
6.1%
13/212 • Up to 1941 days
|
|
Vascular disorders
Hypertension
|
29.7%
63/212 • Up to 1941 days
|
27.6%
59/214 • Up to 1941 days
|
32.5%
69/212 • Up to 1941 days
|
|
Vascular disorders
Hypotension
|
8.0%
17/212 • Up to 1941 days
|
8.9%
19/214 • Up to 1941 days
|
8.0%
17/212 • Up to 1941 days
|
|
Vascular disorders
Orthostatic Hypotension
|
4.2%
9/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Infections and infestations
Urinary tract infection
|
23.1%
49/212 • Up to 1941 days
|
14.0%
30/214 • Up to 1941 days
|
19.8%
42/212 • Up to 1941 days
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
24/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
13.7%
29/212 • Up to 1941 days
|
|
Infections and infestations
Oral Candidiasis
|
4.2%
9/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
6.1%
13/212 • Up to 1941 days
|
|
Infections and infestations
Sinusitis
|
3.3%
7/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Investigations
Blood creatinine increased
|
19.3%
41/212 • Up to 1941 days
|
15.0%
32/214 • Up to 1941 days
|
17.0%
36/212 • Up to 1941 days
|
|
Investigations
Weight increased
|
8.5%
18/212 • Up to 1941 days
|
6.5%
14/214 • Up to 1941 days
|
10.4%
22/212 • Up to 1941 days
|
|
Investigations
Blood magnesium decreased
|
9.0%
19/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
5.7%
12/212 • Up to 1941 days
|
|
Investigations
Urine output decreased
|
3.8%
8/212 • Up to 1941 days
|
5.6%
12/214 • Up to 1941 days
|
4.7%
10/212 • Up to 1941 days
|
|
Investigations
Blood phosphorus decreased
|
4.7%
10/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
2.8%
6/212 • Up to 1941 days
|
|
Investigations
Cardiac Murmur
|
5.2%
11/212 • Up to 1941 days
|
3.3%
7/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Psychiatric disorders
Insomnia
|
28.3%
60/212 • Up to 1941 days
|
24.3%
52/214 • Up to 1941 days
|
21.2%
45/212 • Up to 1941 days
|
|
Psychiatric disorders
Anxiety
|
10.8%
23/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
9.9%
21/212 • Up to 1941 days
|
|
Psychiatric disorders
Depression
|
6.1%
13/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
5.2%
11/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.4%
22/212 • Up to 1941 days
|
12.6%
27/214 • Up to 1941 days
|
12.3%
26/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.3%
26/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
9.9%
21/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
7.1%
15/212 • Up to 1941 days
|
7.5%
16/214 • Up to 1941 days
|
5.2%
11/212 • Up to 1941 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.7%
12/212 • Up to 1941 days
|
4.7%
10/214 • Up to 1941 days
|
3.8%
8/212 • Up to 1941 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
20/212 • Up to 1941 days
|
11.2%
24/214 • Up to 1941 days
|
7.1%
15/212 • Up to 1941 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.1%
13/212 • Up to 1941 days
|
8.4%
18/214 • Up to 1941 days
|
10.4%
22/212 • Up to 1941 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
15/212 • Up to 1941 days
|
6.5%
14/214 • Up to 1941 days
|
1.9%
4/212 • Up to 1941 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
10/212 • Up to 1941 days
|
5.1%
11/214 • Up to 1941 days
|
2.4%
5/212 • Up to 1941 days
|
|
Renal and urinary disorders
Dysuria
|
10.8%
23/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
9.4%
20/212 • Up to 1941 days
|
|
Renal and urinary disorders
Haematuria
|
8.5%
18/212 • Up to 1941 days
|
7.0%
15/214 • Up to 1941 days
|
9.4%
20/212 • Up to 1941 days
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
5/212 • Up to 1941 days
|
6.1%
13/214 • Up to 1941 days
|
4.7%
10/212 • Up to 1941 days
|
|
Cardiac disorders
Tachycardia
|
5.2%
11/212 • Up to 1941 days
|
4.2%
9/214 • Up to 1941 days
|
4.7%
10/212 • Up to 1941 days
|
|
Endocrine disorders
Hirsutism
|
0.00%
0/212 • Up to 1941 days
|
0.00%
0/214 • Up to 1941 days
|
8.5%
18/212 • Up to 1941 days
|
Additional Information
Vice President, Therapeutic Area Head, Transplantation
Astellas Pharma Global Development, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or until 18 months have elapsed following study completion. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document.
- Publication restrictions are in place
Restriction type: OTHER