Trial Outcomes & Findings for Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (NCT NCT00113269)
NCT ID: NCT00113269
Last Updated: 2011-08-11
Results Overview
A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \& Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
501 participants
Primary outcome timeframe
6 months
Results posted on
2011-08-11
Participant Flow
Participant milestones
| Measure |
Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
70
|
175
|
180
|
|
Overall Study
Received Treatment
|
70
|
69
|
164
|
171
|
|
Overall Study
COMPLETED
|
51
|
48
|
134
|
140
|
|
Overall Study
NOT COMPLETED
|
25
|
22
|
41
|
40
|
Reasons for withdrawal
| Measure |
Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Overall Study
Not transplanted, donor issues
|
4
|
0
|
2
|
2
|
|
Overall Study
Not transplanted, recipient issues
|
2
|
1
|
7
|
4
|
|
Overall Study
Early graft loss, technical
|
0
|
0
|
2
|
0
|
|
Overall Study
Death in operating room
|
0
|
0
|
0
|
1
|
|
Overall Study
Did not meet eligibility - pre-treatment
|
0
|
0
|
0
|
2
|
|
Overall Study
Adverse Event
|
2
|
7
|
11
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
4
|
2
|
|
Overall Study
Graft loss
|
6
|
6
|
4
|
9
|
|
Overall Study
Protocol Violation
|
1
|
0
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
6
|
3
|
|
Overall Study
Sponsor elected to discontinue patient
|
1
|
0
|
0
|
1
|
|
Overall Study
Discontinued due to rejection
|
0
|
0
|
1
|
0
|
|
Overall Study
Moved
|
0
|
1
|
0
|
3
|
|
Overall Study
Received pancreas transplant
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrew consent, Prednisone initiated
|
0
|
0
|
0
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
1
|
0
|
0
|
1
|
|
Overall Study
Unable to return for follow up
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
Between 18 and 64 years
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
421 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
304 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
354 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Previous Transplant
Yes
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Previous Transplant
No
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
445 Participants
n=21 Participants
|
|
Type of Transplant
Living related
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Type of Transplant
Living non-related
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Type of Transplant
Deceased
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Panel Reactive Antibody (PRA) Group
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Panel Reactive Antibody (PRA) Group
0%
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
329 Participants
n=21 Participants
|
|
Panel Reactive Antibody (PRA) Group
> 0% - 20%
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Panel Reactive Antibody (PRA) Group
> 20% - 50%
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Panel Reactive Antibody (PRA) Group
> 50%
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \& Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
|
6.2 Percentage of Patients
Interval 0.3 to 12.0
|
9.4 Percentage of Patients
Interval 2.2 to 16.7
|
1.9 Percentage of Patients
Interval 0.0 to 4.0
|
17.5 Percentage of Patients
Interval 11.7 to 23.3
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A \& 1B) to Moderate (2A \& 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Overall Patient Incidence of BCAR
|
15.7 Percentage of Patients
|
13.0 Percentage of Patients
|
9.8 Percentage of Patients
|
21.6 Percentage of Patients
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Efficacy Failure
|
22.9 Percentage of Patients
|
29.0 Percentage of Patients
|
15.9 Percentage of Patients
|
24.6 Percentage of Patients
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Clinically Treated Acute Rejection
|
22.9 Percentage of Patients
|
21.7 Percentage of Patients
|
12.8 Percentage of Patients
|
26.9 Percentage of Patients
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients who experienced BCAR were included in the analysis.
Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=11 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=9 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=15 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=36 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Time to First BCAR
|
226 Days
Interval 25.0 to 1023.0
|
49 Days
Interval 10.0 to 769.0
|
469 Days
Interval 53.0 to 1065.0
|
13 Days
Interval 2.0 to 848.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Graft Survival at 12 Months
|
95.6 Percentage of Patients
|
92.1 Percentage of Patients
|
97.5 Percentage of Patients
|
95.1 Percentage of Patients
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Overall Graft Survival
|
88.6 Percentage of Patients
|
82.6 Percentage of Patients
|
90.9 Percentage of Patients
|
91.2 Percentage of Patients
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Patient survival is defined as not dead within 12 months after skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Patient Survival at 12 Months
|
98.6 Percentage of Patients
|
96.9 Percentage of Patients
|
98.1 Percentage of Patients
|
98.7 Percentage of Patients
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Overall Patient Survival
|
95.7 Percentage of Patients
|
89.9 Percentage of Patients
|
93.9 Percentage of Patients
|
95.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: 1 month and End of Study (36 months)Population: The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as "N".
Increases in creatinine clearance usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Renal Function Abnormalities Based on Creatinine Clearance
Month 1 (N= 65; 65; 162; 161)
|
0.882 mL/s
Standard Deviation 0.3585
|
0.833 mL/s
Standard Deviation 0.2515
|
0.906 mL/s
Standard Deviation 0.2720
|
0.891 mL/s
Standard Deviation 0.2668
|
|
Renal Function Abnormalities Based on Creatinine Clearance
Month 36 (N= 48; 47; 125; 131)
|
0.976 mL/s
Standard Deviation 0.3772
|
0.862 mL/s
Standard Deviation 0.2929
|
1.011 mL/s
Standard Deviation 0.2736
|
1.039 mL/s
Standard Deviation 0.3195
|
|
Renal Function Abnormalities Based on Creatinine Clearance
Change from Month 1 (N= 48; 46; 125; 129)
|
0.031 mL/s
Standard Deviation 0.3599
|
0.039 mL/s
Standard Deviation 0.2649
|
0.080 mL/s
Standard Deviation 0.2592
|
0.140 mL/s
Standard Deviation 0.2698
|
SECONDARY outcome
Timeframe: 1 month and End of Study (36 months)Population: The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as "N".
Decrease in serum creatinine usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1.
Outcome measures
| Measure |
Alemtuzumab High-Risk Patients
n=70 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 Participants
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 Participants
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 Participants
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Renal Function Abnormalities Based on Serum Creatinine
Month 1 (N= 67; 65; 163; 162)
|
151.7 mcmol/L
Standard Deviation 88.12
|
155.9 mcmol/L
Standard Deviation 97.18
|
139.0 mcmol/L
Standard Deviation 56.82
|
138.2 mcmol/L
Standard Deviation 46.03
|
|
Renal Function Abnormalities Based on Serum Creatinine
Month 36 (N= 49; 47; 126; 131)
|
136.6 mcmol/L
Standard Deviation 68.38
|
152.0 mcmol/L
Standard Deviation 84.85
|
121.7 mcmol/L
Standard Deviation 40.09
|
117.1 mcmol/L
Standard Deviation 35.50
|
|
Renal Function Abnormalities Based on Serum Creatinine
Change from Month 1 (N= 49; 46; 126; 129)
|
1.8 mcmol/L
Standard Deviation 69.41
|
3.4 mcmol/L
Standard Deviation 92.80
|
-8.0 mcmol/L
Standard Deviation 44.07
|
-18.7 mcmol/L
Standard Deviation 42.35
|
Adverse Events
Alemtuzumab High-Risk Patients
Serious events: 33 serious events
Other events: 61 other events
Deaths: 0 deaths
Conventional High-Risk Patients
Serious events: 40 serious events
Other events: 66 other events
Deaths: 0 deaths
Alemtuzumab Low- Risk Patients
Serious events: 91 serious events
Other events: 151 other events
Deaths: 0 deaths
Conventional Low-Risk Patients
Serious events: 81 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alemtuzumab High-Risk Patients
n=70 participants at risk
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 participants at risk
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 participants at risk
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 participants at risk
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cryptococcosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Ear infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
8.7%
6/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.7%
6/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
4/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.4%
4/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.5%
6/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Bk virus infection
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
3/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.0%
5/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Bacteraemia
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.7%
6/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.0%
5/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Bacterial pyelonephritis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cytomegalovirus colitis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Endocarditis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Influenza
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Osteomyelitis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumonia aspergillus
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pyelonephritis acute
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Urosepsis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
7/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Wound infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Gangrene
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Orchitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Candida osteomyelitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Gastroenteritis norwalk virus
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Human polyomavirus infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pericarditis infective
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Pneumonitis cryptococcal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Postoperative infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Varicella
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
West nile viral infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Blood creatinine increased
|
7.1%
5/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.2%
5/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
7/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.8%
10/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Immunosuppressant drug level increased
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Pulmonary function test increased
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Protein urine present
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Bacteria urine identified
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Blood culture positive
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Cytomegalovirus antigen positive
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Troponin increased
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
5.7%
4/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.7%
6/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.0%
12/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.3%
9/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Stenosis of vesicourethral anastomosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Treatment noncompliance
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.4%
4/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.5%
6/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.1%
7/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
5/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Hypotension
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Aneurysm arteriovenous
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Peripheral occlusive disease
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.4%
4/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.9%
8/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Coronary artery atherosclerosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
General disorders
Chest pain
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
General disorders
Death
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
General disorders
Heparin-induced thrombocytopenia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
General disorders
Pyrexia
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
General disorders
Chills
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Immune system disorders
Transplant rejection
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
3/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Immune system disorders
Kidney transplant rejection
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.3%
4/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Nephropathy
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.5%
6/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Nephritis interstitial
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Hepatobiliary disorders
Hepatitis
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Leukoencephalopathy
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Mental impairment
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Headache
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.2%
2/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.8%
3/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Psychiatric disorders
Mania
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.58%
1/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.61%
1/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
0.00%
0/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
Other adverse events
| Measure |
Alemtuzumab High-Risk Patients
n=70 participants at risk
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Conventional High-Risk Patients
n=69 participants at risk
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
|
Alemtuzumab Low- Risk Patients
n=164 participants at risk
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
Conventional Low-Risk Patients
n=171 participants at risk
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
58.6%
41/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
59.4%
41/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
54.9%
90/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
42.7%
73/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
54.3%
38/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
58.0%
40/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
51.2%
84/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
28.1%
48/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.4%
8/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
3/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
14.0%
23/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.6%
13/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
10.1%
7/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.3%
12/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.3%
4/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.9%
23/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
26.1%
18/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
32.3%
53/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
38.0%
65/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
8/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
14.5%
10/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
9.8%
16/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
6.4%
11/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
4/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
10.1%
7/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.3%
12/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.7%
8/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
BK Viris infection
|
4.3%
3/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
10.1%
7/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
6.1%
10/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.3%
9/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Bronchitis
|
4.3%
3/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
8.7%
6/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.9%
8/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.3%
9/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.9%
2/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.8%
4/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
6.7%
11/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.5%
6/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
2/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.5%
9/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.7%
8/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
4/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
8.7%
6/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
16.5%
27/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
13.5%
23/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Urinary tract infection
|
25.7%
18/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
20.3%
14/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
19.5%
32/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
21.6%
37/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.2%
5/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
3.0%
5/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
2.9%
5/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
8.6%
6/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
17.4%
12/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
9.8%
16/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.6%
13/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
1.4%
1/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
5.8%
4/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.9%
8/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
7.6%
13/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Investigations
Blood creatinine increased
|
10.0%
7/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
3/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
11.0%
18/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
8.2%
14/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.7%
4/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.3%
7/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
12.3%
21/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.9%
9/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
10.1%
7/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
6.7%
11/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
6.4%
11/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
17.1%
12/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
23.2%
16/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
20.1%
33/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
18.7%
32/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Nervous system disorders
Tremor
|
0.00%
0/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
1.4%
1/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
6.1%
10/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
4.1%
7/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
|
Vascular disorders
Hypertension
|
12.9%
9/70
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
10.1%
7/69
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
15.2%
25/164
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
10.5%
18/171
Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus. Within a system organ class patients may have reported more than one type of event.
|
Additional Information
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. 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. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER