Trial Outcomes & Findings for To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients (NCT NCT02723591)
NCT ID: NCT02723591
Last Updated: 2024-12-18
Results Overview
DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching mean fluorescence intensity (MFI)=1000 at any time during the study. IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
599 participants
Primary outcome timeframe
From date of transplant until 1 year
Results posted on
2024-12-18
Participant Flow
Participants of ≥16 years and ≤70 of age requiring kidney transplant were enrolled. Randomization was stratified by alemtuzumab (yes/no), kidney donor profile index (KDPI) (3 levels: N/A \[living donors\] versus ≤50 versus \>50), and human leukocyte antigens (HLA) Class II mismatch (yes/no).
Participant milestones
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 milligram per kilogram (mg/kg), once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 nanogram per milliliter (ng/mL) at all times during the study.
|
Tacrolimus, Immediate Release Twice Daily (BID)
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
299
|
|
Overall Study
COMPLETED
|
204
|
198
|
|
Overall Study
NOT COMPLETED
|
96
|
101
|
Reasons for withdrawal
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 milligram per kilogram (mg/kg), once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 nanogram per milliliter (ng/mL) at all times during the study.
|
Tacrolimus, Immediate Release Twice Daily (BID)
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
48
|
40
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
7
|
|
Overall Study
Protocol Violation
|
20
|
23
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
|
Overall Study
Randomized but Never Received StudyDrug
|
12
|
12
|
|
Overall Study
Miscellaneous
|
5
|
6
|
Baseline Characteristics
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=300 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=299 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Total
n=599 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
48.5 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
48.8 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
189 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
268 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
533 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
212 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The Modified Full Analysis Set (mFAS) consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching mean fluorescence intensity (MFI)=1000 at any time during the study. IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Positive for de Novo DSA (dnDSA) or Immune Activation (IA) Occurrence
|
35.6 percentage of participants
|
34.4 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching MFI=1000 at any time during the study. Indeterminate was defined as MFI signal was \>1000 and DSA was suspected, but could not be confirmed due to inadequate donor typing. Participants whose samples for the test were not available were reported as unknown.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Positive, Negative or Indeterminate for dnDSA Occurrence
Positive
|
5.5 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants Who Were Positive, Negative or Indeterminate for dnDSA Occurrence
Negative
|
90.5 percentage of participants
|
92.8 percentage of participants
|
|
Percentage of Participants Who Were Positive, Negative or Indeterminate for dnDSA Occurrence
Indeterminate
|
4 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants Who Were Positive, Negative or Indeterminate for dnDSA Occurrence
Unknown
|
0 percentage of participants
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for dnDSA were included in the analyses.
Peak MFI of DSA positive participants was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=15 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=12 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Peak Mean Fluorescence Intensity (MFI) of DSA Positive Participants
|
6119.21 fluorescence intensity unit
Interval 1320.0 to 29317.6
|
2727.99 fluorescence intensity unit
Interval 1066.0 to 19971.5
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for dnDSA were included in the analyses.
DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching MFI=1000 at any time during the study.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=15 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=12 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of DSA Positive Participants With Weak, Moderate and Strong Antibody Strentgh
Weak
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of DSA Positive Participants With Weak, Moderate and Strong Antibody Strentgh
Moderate
|
73.3 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of DSA Positive Participants With Weak, Moderate and Strong Antibody Strentgh
Strong
|
26.7 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for dnDSA were included in the analyses.
DSA was regarded as persistent under the following conditions: (i) DSA was detected and remained above the threshold for positivity (MFI = 1000) for two consecutive or nonconsecutive measurements, or (ii) the new appearance of a DSA at the threshold for positivity when preceded by a DSA of a different specificity that had subsequently become non-detectable.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=15 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=12 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of DSA Positive Participants With DSA Persistence
|
73.3 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Percentage of participants who were positive or negative for C1q-binding DSA were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Positive or Negative for Complement Component 1, Q Subcomponent (C1q)-Binding DSA
Positive
|
1.8 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Who Were Positive or Negative for Complement Component 1, Q Subcomponent (C1q)-Binding DSA
Negative
|
98.2 percentage of participants
|
99.6 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Percentage of participants who were positive or negative for IgG3 isotype were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Positive or Negative for DSA Immunoglobulin G (IgG3) Isotype
Positive
|
0.7 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants Who Were Positive or Negative for DSA Immunoglobulin G (IgG3) Isotype
Negative
|
99.3 percentage of participants
|
98.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. Only those mFAS participants who tested positive for DSA were included in the analyses.
Percentage of DSA positive participants with HLA-DQ Class-II were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=15 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=12 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of DSA Positive Participants With Human Leukocyte Antigen, Class II, DQ Locus (HLA-DQ)
|
40 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: From day 1 to day 365 visitPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Positive for IA Occurrence From Day 1 to Day 365 Visit
|
31.3 percentage of participants
|
31.2 percentage of participants
|
SECONDARY outcome
Timeframe: From day 30 to day 365 visitPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Positive for IA Occurrence From Day 30 to Day 365 Visit
|
21.8 percentage of participants
|
21.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
IA was regarded as persistent under the following conditions: (i) IA was detected and remained above the threshold for positivity for two consecutive or non-consecutive measurements, or (ii) the new appearance of an IA at the threshold for positivity when preceded by an IA of a different specificity that had subsequently become non-detectable.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With IA Persistence
|
7.3 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The Biopsy Analysis Dataset (BAS) consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
TG was defined as chronic glomerulopathy (cg) \>0 on centrally-interpreted institutional protocol biopsy or biopsy obtained for cause during the first year post-transplant with +2 months visit window.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Presence of Transplant Glomerulopathy (TG) on Biopsy
|
6.5 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
MI was defined as glomerulitis (g) + peritubular capillaritis (ptc)\>=2 on centrally-interpreted institutional protocol biopsy or biopsy obtained for cause during the first year post-transplant, with +2 months visit window.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Presence of Microcirculatory Inflammation (MI) on Biopsy
|
8.9 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
IFTA and inflammation was defined as IFTA positive and inflammation positive (i \>0) on centrally-interpreted institutional protocol biopsy or biopsy obtained for cause during the first year posttransplant, with +2 months visit window.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Presence of Interstitial Fibrosis and Tubular Atrophy (IFTA) and Inflammation on Biopsy
|
26 percentage of participants
|
16.9 percentage of participants
|
SECONDARY outcome
Timeframe: At 1 year post transplantPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
The eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Threshold of <30 Millimetre Per Minute Per 1.73 Meter Square (mL/Min/1.73m^2)
|
1.5 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: At 1 year post transplantPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
The eGFR was calculated using the MDRD formula.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With eGFR Threshold of <40 mL/Min/1.73m^2
|
9.5 percentage of participants
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: At 1 year post transplantPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
The eGFR was calculated using the MDRD formula.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With eGFR Threshold of <50 mL/Min/1.73m^2
|
25.5 percentage of participants
|
19.7 percentage of participants
|
SECONDARY outcome
Timeframe: From 30 days post transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
The eGFR was calculated using the MDRD formula.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With a Five-point Decline in eGFR
|
13.1 percentage of participants
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 30, day 90, day 180, day 270 and day 365Population: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study. mFAS population with available data at each time point.
The eGFR was calculated using the MDRD formula.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=265 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=271 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
eGFR at Day 30, Day 90, Day 180, Day 270 and Day 365
Day 90
|
55.56 mL/min/1.73 m^2
Standard Deviation 16.00
|
57.10 mL/min/1.73 m^2
Standard Deviation 19.99
|
|
eGFR at Day 30, Day 90, Day 180, Day 270 and Day 365
Day 30
|
50.86 mL/min/1.73 m^2
Standard Deviation 17.27
|
52.72 mL/min/1.73 m^2
Standard Deviation 19.40
|
|
eGFR at Day 30, Day 90, Day 180, Day 270 and Day 365
Day 180
|
56.81 mL/min/1.73 m^2
Standard Deviation 15.84
|
58.33 mL/min/1.73 m^2
Standard Deviation 17.51
|
|
eGFR at Day 30, Day 90, Day 180, Day 270 and Day 365
Day 270
|
57.19 mL/min/1.73 m^2
Standard Deviation 16.84
|
59.04 mL/min/1.73 m^2
Standard Deviation 18.19
|
|
eGFR at Day 30, Day 90, Day 180, Day 270 and Day 365
Day 365
|
58.25 mL/min/1.73 m^2
Standard Deviation 16.51
|
60.94 mL/min/1.73 m^2
Standard Deviation 17.83
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Graft loss was defined as re-transplantation, transplant nephrectomy, or a return to dialysis for at least a six week duration, or participants' death.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Graft Loss
|
1.5 percentage of participants
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Percentage of participants who died were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Died
|
0.7 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Positivity was determined by local biopsy, central pathology, or reported adverse events.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)
|
7.6 percentage of participants
|
8.2 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Percentage of participants who were lost to follow-up were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants Who Were Lost to Follow-up
|
0 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Percentage of participants with either graft loss, death, BPAR or lost to follow-up were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Either Graft Loss, Death, BPAR or Lost to Follow-up
|
9.1 percentage of participants
|
10.4 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Percentage of participants with ABMR were reported. Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. A positive assessment is defined as antibody mediated changes that are diagnosed as either acute ABMR or chronic active ABMR.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Any Antibody-Mediated Rejection (ABMR)
|
1.6 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Percentage of participants with normal biopsy findings were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Normal Biopsy Findings
|
6.5 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 posttransplant central pathology assessment.
Percentage of participants with C4d deposition without active rejection were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With C4d Deposition Without Active Rejection
|
0.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 posttransplant central pathology assessment.
Percentage of participants with acute ABMR were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Acute ABMR
|
1.6 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. Only those BAS participants who had acute AMBR were included in the analyses.
Percentage of participants with grade I, II and III acute ABMR were reported. Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Acute ABMR was graded as Grade I: acute tubular necrosis-like -like minimal inflammation, Grade II: Capillary and or glomerular inflammation (ptc/g \>0) and/or thromboses, and Grade III: arterial - v3.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=2 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=1 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Grade I, II and III Acute ABMR
Grade I
|
50 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Grade I, II and III Acute ABMR
Grade II
|
50 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Grade I, II and III Acute ABMR
Grade III
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Percentage of participants with chronic ABMR were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Chronic ABMR
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Percentage of participants with borderline changes were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Borderline Changes
|
14.6 percentage of participants
|
14.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Percentage of participants with acute TCMR were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Acute T-cell Mediated Rejection (TCMR)
|
6.5 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment. Only those BAS participants who had TCMR were included in the analyses.
Percentage of participants with chronic TCMR were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=8 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=8 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Chronic TCMR
|
25 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Percentage of participants with Grade I, II and III IFTA were reported. Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. IFTA was graded as Grade I: mild interstitial fibrosis and tubular atrophy (\<25% of cortical area), Grade II: moderate interstitial fibrosis and tubular atrophy (26-50% of cortical area), and Grade III: severe interstitial fibrosis and tubular atrophy/ loss (\>50% of cortical area).
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Grade I, II and III IFTA
Grade I
|
54.5 percentage of participants
|
56.6 percentage of participants
|
|
Percentage of Participants With Grade I, II and III IFTA
Grade II
|
18.7 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Grade I, II and III IFTA
Grade III
|
5.7 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Percentage of participants with any additional findings (other than Normal biopsy, borderline changes, acute and chronic ABMR, Grade I, II, and III ABMR, C4D deposition, acute and chronic TCMR, Grade I, II, and III TCMR, Grade I, II and III IFTA, acute tubular necrosis, interstitial nephritis, pyelonephritis, bk virus, calcineurin inhibitor toxicity, hemolytic uremic syndrome and recurrent disease) were reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Any Additional Findings
|
29.3 percentage of participants
|
34.6 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No glomerulitis, Score 1= \<25% glomerulitis, Score 2= 25 to 75% glomerulitis and Score 3= \>75% glomerulitis.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Glomerulitis (g) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
89.4 percentage of participants
|
90.4 percentage of participants
|
|
Percentage of Participants With Glomerulitis (g) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
5.7 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Glomerulitis (g) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
4.1 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Glomerulitis (g) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Glomerulitis (g) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No mononuclear cells in tubules or single focus of tubulitis only, Score 1= Foci with 1 to 4 mononuclear cells/tubular cross section (or 10 tubular cells), Score 2= Foci with 5 to 10 mononuclear cells/tubular cross section (or 10 tubular cells) and Score 3= Foci with \>10 mononuclear cells/tubular cross section or the presence of ≥2 areas of tubular basement membrane destruction accompanied by i2/i3 inflammation and t2 elsewhere.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Tubulitis (t) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
79.7 percentage of participants
|
79.4 percentage of participants
|
|
Percentage of Participants With Tubulitis (t) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
16.3 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Tubulitis (t) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
1.6 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Tubulitis (t) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
1.6 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Tubulitis (t) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No arteritis, Score 1= Mild to moderate intimal arteritis in at least 1 arterial cross section, Score 2= Severe intimal arteritis with at least 25% luminal area lost in at least 1 arterial cross section and Score 3= Transmural arteritis and/or arterial fibrinoid change and medial smooth muscle necrosis with lymphocytic infiltrate in vessel.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Intimal Arteritis (v) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
93.5 Percentage of Participants
|
94.9 Percentage of Participants
|
|
Percentage of Participants With Intimal Arteritis (v) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
2.4 Percentage of Participants
|
2.2 Percentage of Participants
|
|
Percentage of Participants With Intimal Arteritis (v) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
2.4 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Intimal Arteritis (v) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Intimal Arteritis (v) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
1.6 Percentage of Participants
|
2.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No inflammation or in less than 10% of unscarred cortical parenchyma, Score 1= Inflammation in 10 to 25% of unscarred cortical parenchyma, Score 2= Inflammation in 26 to 50% of unscarred cortical parenchyma and Score 3= Inflammation in more than 50% of unscarred cortical parenchyma.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Mononuclear Cell Interstitial Inflammation (i) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Mononuclear Cell Interstitial Inflammation (i) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
68.3 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants With Mononuclear Cell Interstitial Inflammation (i) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
26.8 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With Mononuclear Cell Interstitial Inflammation (i) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
4.1 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Mononuclear Cell Interstitial Inflammation (i) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No GBM double contours by light microscopy (LM) or electron microscopy (EM), Score 1= No GBM double contours by LM but GBM double contours (incomplete or circumferential) in at least 3 glomerular capillaries by EM or Double contours of the GBM in 1-25% of capillary loops in the most affected nonsclerotic glomerulus by LM , Score 2= Double contours affecting 26 to 50% of peripheral capillary loops in the most affected-glomerulus and Score 3= Double contours affecting more than 50% of peripheral capillary loops in the most affected-glomerulus.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Glomerular Basement Membrane Double Contours (cg) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
0 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Glomerular Basement Membrane Double Contours (cg) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
93.5 percentage of participants
|
93.4 percentage of participants
|
|
Percentage of Participants With Glomerular Basement Membrane Double Contours (cg) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
5.7 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Glomerular Basement Membrane Double Contours (cg) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Glomerular Basement Membrane Double Contours (cg) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No tubular atrophy, Score 1= Tubular atrophy involving up to 25% of the area of cortical tubules, Score 2= Tubular atrophy involving 26 to 50% of the area of cortical tubules and Score 3= Tubular atrophy involving in \>50% of the area of cortical tubules.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Tubular Atrophy (ct) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
20.3 percentage of participants
|
21.3 percentage of participants
|
|
Percentage of Participants With Tubular Atrophy (ct) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
53.7 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With Tubular Atrophy (ct) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
19.5 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Tubular Atrophy (ct) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
5.7 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Tubular Atrophy (ct) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= Interstitial fibrosis in up to 5% of cortical area, Score 1= Interstitial fibrosis in 6 to 25%of cortical area (mild interstitial fibrosis), Score 2= Interstitial fibrosis in 26 to 50% of cortical area (moderate interstitial fibrosis) and Score 3= Interstitial fibrosis in \>50% of cortical area (severe interstitial fibrosis).
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Interstitial Fibrosis (ci) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
21.1 percentage of participants
|
20.6 percentage of participants
|
|
Percentage of Participants With Interstitial Fibrosis (ci) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
52.8 percentage of participants
|
56.6 percentage of participants
|
|
Percentage of Participants With Interstitial Fibrosis (ci) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
19.5 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants With Interstitial Fibrosis (ci) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
5.7 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Interstitial Fibrosis (ci) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had atleast 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No chronic vascular changes, Score 1= Vascular narrowing of up to 25% luminal area by fibrointimal thickening, Score 2= Vascular narrowing of 26 to 50% luminal area by fibrointimal thickening and Score 3= Vascular narrowing of more than 50% luminal area by fibrointimal thickening.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Vascular Fibrous Intimal Thickening (cv) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
33.3 percentage of participants
|
36 percentage of participants
|
|
Percentage of Participants With Vascular Fibrous Intimal Thickening (cv) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
40.7 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Participants With Vascular Fibrous Intimal Thickening (cv) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
22 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With Vascular Fibrous Intimal Thickening (cv) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
2.4 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Vascular Fibrous Intimal Thickening (cv) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
1.6 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No periodic acid-Schiff (PAS)-positive hyaline arteriolar thickening, Score 1= Mild to moderate PAS-positive hyaline thickening in at least 1 arteriole, Score 2= Moderate to severe PAS-positive hyaline thickening in more than 1 arteriole and Score 3= Severe PAS-positive hyaline thickening in many arterioles.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Arteriolar Hyalinosis (ah) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
91.1 percentage of participants
|
86.8 percentage of participants
|
|
Percentage of Participants With Arteriolar Hyalinosis (ah) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
4.1 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Arteriolar Hyalinosis (ah) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
4.1 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Arteriolar Hyalinosis (ah) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Arteriolar Hyalinosis (ah) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= Maximum number of leukocytes \<3, Score 1= At least 1 leukocyte cell in ≥10% of cortical PTCs with 3-4 leukocytes in most severely involved PTC, Score 2= At least 1 leukocyte in ≥10% of cortical PTC with 5-10 leukocytes in most severely involved PTC and Score 3= At least 1 leukocyte in ≥10% of cortical PTC with \>10 leukocytes in most severely involved PTC.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Peritubular Capillaritis (Ptc) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
91.1 percentage of participants
|
90.4 percentage of participants
|
|
Percentage of Participants With Peritubular Capillaritis (Ptc) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
3.3 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Peritubular Capillaritis (Ptc) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
4.9 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Peritubular Capillaritis (Ptc) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Peritubular Capillaritis (Ptc) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until month 14Population: The BAS consisted of all mFAS participants who had at least 1 post-transplant central pathology assessment.
Central pathology reading was performed as per the 2007 Update to the Banff '97 classification. Banff Lesion Scores assess the presence and the degree of histopathological changes in the different compartments of renal transplant biopsies, focusing primarily but not exclusively on the diagnostic features seen in rejection. \[Roufosse C et. al 2018\]. Here, Score 0= No more than mild mesangial matrix increase in any glomerulus, Score 1= At least moderate mesangial matrix increase in up to 25% of nonsclerotic glomeruli, Score 2= At least moderate mesangial matrix increase in 26% to 50% of nonsclerotic glomeruli and Score 3= At least moderate mesangial matrix increase in \>50% of nonsclerotic glomeruli.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=123 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=136 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Mesangial Matrix Expansion (mm) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 0
|
87.8 percentage of participants
|
91.2 percentage of participants
|
|
Percentage of Participants With Mesangial Matrix Expansion (mm) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 1
|
8.9 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Mesangial Matrix Expansion (mm) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 2
|
2.4 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Mesangial Matrix Expansion (mm) Biopsy Score Assessed Using Banff Lesion Scores
Banff Lesion Score 3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Mesangial Matrix Expansion (mm) Biopsy Score Assessed Using Banff Lesion Scores
Not able to score
|
0.8 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching MFI=1000 at any time during the study.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of DSA
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of HLA-DQ DSA was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of HLA-DQ DSA
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of C1q-binding DSA was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of C1q-binding DSA
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of DSA IgG3 isotype was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of DSA IgG3 Isotype
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of IA was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of IA
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of TG on biopsy was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of TG on Biopsy
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to occurrence of death was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to Occurrence of Death
|
NA days
No data is reported since median and confidence interval was not estimable (that is, not reached) in either treatment group due to low number of events.
|
NA days
No data is reported since median and confidence interval was not estimable (that is, not reached) in either treatment group due to low number of events.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of local BPAR was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of Local BPAR
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of acute forms of ABMR was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of Acute Forms of ABMR
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of chronic forms of ABMR was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of Chronic Forms of ABMR
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of acute TCMR was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of Acute TCMR
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of chronic TCMR was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of Chronic TCMR
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of borderline changes was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of Borderline Changes
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From date of transplant until 1 yearPopulation: The mFAS consisted of all participants who were randomized and who received at least 1 dose of study drug (Astagraf XL or BID tacrolimus), and whose pretransplant cross-matched antibody samples did not demonstrate preformed DSA for the duration of the study.
Time to first occurrence of IFTA was reported.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=275 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=279 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Time to First Occurrence of IFTA
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
NA days
Standard Deviation NA
Analysis of data was not performed because it was not possible to define the exact date of occurrence since the data only recorded the date of sample collection which could not be interpreted as the date of first occurrence.
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)Population: The Safety Analysis Set (SAF) consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
A TEAE was defined as an Adverse Event (AE) observed on or after the day of starting the administration of the test drug/comparative drug.
Outcome measures
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=288 Participants
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=287 Participants
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death
TEAEs
|
99.7 percentage of participants
|
98.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death
TEAEs related to study treatment
|
77.8 percentage of participants
|
70.7 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death
TESAEs
|
56.6 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death
TESAEs related to study treatment
|
27.4 percentage of participants
|
23.7 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death
TEAEs causing discontinuation of study treatment
|
16.3 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Event(TEAEs), Related TEAEs, Treatment-emergent Serious Adverse Event (TESAEs), Related TESAEs, TEAEs Leading to Discontinuation of Study Treatment and TEAEs Leading to Death
TEAEs leading to death
|
0.7 percentage of participants
|
0.7 percentage of participants
|
Adverse Events
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
Serious events: 163 serious events
Other events: 285 other events
Deaths: 2 deaths
Tacrolimus, Immediate Release BID
Serious events: 136 serious events
Other events: 278 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=288 participants at risk
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=287 participants at risk
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.1%
6/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
5/288 • Number of events 7 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Angina pectoris
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Bradycardia
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Coronary artery disease
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Left ventricular failure
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.1%
6/287 • Number of events 10 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
7/288 • Number of events 7 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
3.8%
11/287 • Number of events 11 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.4%
4/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.69%
2/288 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
4/288 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Odynophagia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.35%
1/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/288 • Number of events 7 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.4%
7/287 • Number of events 10 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Asthenia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Chest pain
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Death
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Fatigue
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Haemorrhagic cyst
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Implant site extravasation
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Malaise
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Oedema peripheral
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Peripheral swelling
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Pyrexia
|
3.1%
9/288 • Number of events 10 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.8%
8/287 • Number of events 11 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Immune system disorders
Anaphylactic reaction
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Immune system disorders
Kidney transplant rejection
|
4.2%
12/288 • Number of events 13 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
4.9%
14/287 • Number of events 17 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Immune system disorders
Renal transplant failure
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Immune system disorders
Transplant rejection
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Bacteraemia
|
1.4%
4/288 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.4%
4/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Bronchitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Cellulitis
|
1.4%
4/288 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.4%
4/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Clostridium difficile infection
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.1%
6/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Coccidioidomycosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Cystitis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.4%
4/288 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.1%
6/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Diabetic foot infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Disseminated cytomegaloviral infection
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Enterovirus infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.0%
3/288 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Fungal oesophagitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Gangrene
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
4/288 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Infected cyst
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Infection in an immunocompromised host
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Influenza
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Localised infection
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Osteomyelitis
|
1.0%
3/288 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Paronychia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Peritonitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Peritonitis bacterial
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pneumonia
|
3.5%
10/288 • Number of events 11 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.4%
7/287 • Number of events 8 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pneumonia legionella
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pyelonephritis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Pyelonephritis acute
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Rhinovirus infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Sepsis
|
2.4%
7/288 • Number of events 7 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
3.5%
10/287 • Number of events 10 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Septic shock
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Skin infection
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Tooth infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
16/288 • Number of events 17 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
3.8%
11/287 • Number of events 12 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Urosepsis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Viral infection
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Viral pharyngitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Wound infection
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
1.7%
5/288 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.4%
4/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Fall
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.35%
1/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Psychosis postoperative
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Wound haematoma
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Blood creatinine increased
|
3.5%
10/288 • Number of events 12 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
2.8%
8/287 • Number of events 9 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Blood potassium increased
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Clostridium test positive
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Hepatic enzyme increased
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Histology abnormal
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Immunosuppressant drug level increased
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Mycobacterium test positive
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 7 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
7/288 • Number of events 7 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
15/288 • Number of events 16 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Dizziness
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Headache
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Ischaemic stroke
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Presyncope
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Syncope
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Product Issues
Device dislocation
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Psychiatric disorders
Mental status changes
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.0%
26/288 • Number of events 33 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
10.8%
31/287 • Number of events 36 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Azotaemia
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.69%
2/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Haematuria
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Perinephric collection
|
1.0%
3/288 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Renal pain
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Renal tubular injury
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Urinary retention
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
5/288 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.0%
3/287 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal necrosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
3/288 • Number of events 3 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Surgical and medical procedures
Therapy change
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Arteriosclerosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Deep vein thrombosis
|
2.1%
6/288 • Number of events 6 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.7%
5/287 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Extremity necrosis
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Extrinsic iliac vein compression
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Haematoma
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Hypertension
|
1.7%
5/288 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.4%
4/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Hypertensive crisis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Hypotension
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
1.4%
4/287 • Number of events 4 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Lymphocele
|
0.69%
2/288 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Orthostatic hypotension
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.70%
2/287 • Number of events 2 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Steal syndrome
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.35%
1/288 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.00%
0/287 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/288 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
0.35%
1/287 • Number of events 1 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
Other adverse events
| Measure |
Tacrolimus, Extended Release (Astagraf XL®) Once Daily
n=288 participants at risk
Participants received tacrolimus extended release capsule (Astagraf XL) at a starting dose of 0.15 mg/kg, once daily, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
Tacrolimus, Immediate Release BID
n=287 participants at risk
Participants received tacrolimus immediate release capsule as per the institutionally-derived protocol, BID, orally within 48 hours of transplantation (per the treating physician's discretion) for up to 1 year. Dose adjustments were allowed such that participants receiving tacrolimus maintained a minimal trough concentration of 6 ng/mL at all times during the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.6%
42/288 • Number of events 46 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
12.9%
37/287 • Number of events 45 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.2%
12/288 • Number of events 12 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.9%
66/288 • Number of events 74 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
20.2%
58/287 • Number of events 67 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
20/288 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
9.8%
28/287 • Number of events 30 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.9%
14/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.3%
18/287 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Cardiac disorders
Tachycardia
|
9.4%
27/288 • Number of events 28 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
8.4%
24/287 • Number of events 25 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.9%
14/288 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 27 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
31/288 • Number of events 34 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
12.2%
35/287 • Number of events 39 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
90/288 • Number of events 101 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
34.8%
100/287 • Number of events 113 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
128/288 • Number of events 165 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
40.1%
115/287 • Number of events 160 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
24/288 • Number of events 26 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
8.4%
24/287 • Number of events 29 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.2%
15/288 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
3.1%
9/287 • Number of events 9 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Nausea
|
35.1%
101/288 • Number of events 131 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
36.2%
104/287 • Number of events 133 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Gastrointestinal disorders
Vomiting
|
14.2%
41/288 • Number of events 54 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
21.3%
61/287 • Number of events 77 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Asthenia
|
7.3%
21/288 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
4.9%
14/287 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Chest pain
|
5.2%
15/288 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
4.2%
12/287 • Number of events 12 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Fatigue
|
15.6%
45/288 • Number of events 48 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
15.7%
45/287 • Number of events 51 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Oedema
|
3.5%
10/288 • Number of events 12 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.9%
17/287 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Oedema peripheral
|
18.4%
53/288 • Number of events 63 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
18.5%
53/287 • Number of events 64 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
General disorders
Pyrexia
|
9.7%
28/288 • Number of events 37 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
13.2%
38/287 • Number of events 44 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
BK virus infection
|
15.6%
45/288 • Number of events 47 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
12.9%
37/287 • Number of events 37 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
6.2%
18/288 • Number of events 21 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.2%
15/287 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
21/288 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.9%
17/287 • Number of events 19 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
25/288 • Number of events 27 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
10.8%
31/287 • Number of events 32 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Infections and infestations
Urinary tract infection
|
17.4%
50/288 • Number of events 65 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
15.3%
44/287 • Number of events 77 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
5.2%
15/288 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
10.5%
30/287 • Number of events 30 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
8.3%
24/288 • Number of events 25 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
16.4%
47/287 • Number of events 50 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
19.1%
55/288 • Number of events 62 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
31.7%
91/287 • Number of events 105 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Blood creatinine increased
|
12.8%
37/288 • Number of events 40 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
15.0%
43/287 • Number of events 49 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Viral test positive
|
3.5%
10/288 • Number of events 11 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.3%
18/287 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Investigations
Weight increased
|
5.6%
16/288 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
4.9%
14/287 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.2%
12/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.0%
20/287 • Number of events 20 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
14/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.2%
18/288 • Number of events 19 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.6%
19/287 • Number of events 19 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.9%
14/288 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.3%
18/287 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.8%
37/288 • Number of events 41 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
20.2%
58/287 • Number of events 62 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
28.1%
81/288 • Number of events 106 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
27.5%
79/287 • Number of events 102 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.2%
18/288 • Number of events 20 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 22 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.8%
37/288 • Number of events 43 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
14.3%
41/287 • Number of events 42 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.2%
12/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.6%
16/287 • Number of events 20 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.2%
38/288 • Number of events 39 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
12.9%
37/287 • Number of events 44 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
43.1%
124/288 • Number of events 142 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
43.2%
124/287 • Number of events 143 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.6%
19/288 • Number of events 21 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.3%
18/287 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
42.4%
122/288 • Number of events 133 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
42.5%
122/287 • Number of events 133 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
17.4%
50/288 • Number of events 57 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
20.9%
60/287 • Number of events 70 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
13.2%
38/288 • Number of events 38 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
12.2%
35/287 • Number of events 35 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
14/288 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.6%
16/287 • Number of events 22 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
19/288 • Number of events 20 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.9%
17/287 • Number of events 17 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
12/288 • Number of events 12 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 22 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
17/288 • Number of events 20 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
8.0%
23/287 • Number of events 27 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Dizziness
|
11.8%
34/288 • Number of events 41 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
10.5%
30/287 • Number of events 36 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Headache
|
16.0%
46/288 • Number of events 58 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
13.2%
38/287 • Number of events 43 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Nervous system disorders
Tremor
|
32.6%
94/288 • Number of events 99 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
29.3%
84/287 • Number of events 89 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Psychiatric disorders
Anxiety
|
4.2%
12/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
8.4%
24/287 • Number of events 29 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Psychiatric disorders
Insomnia
|
13.9%
40/288 • Number of events 42 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
15.3%
44/287 • Number of events 47 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Dysuria
|
9.4%
27/288 • Number of events 30 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Haematuria
|
8.7%
25/288 • Number of events 26 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
10.5%
30/287 • Number of events 30 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
5/288 • Number of events 5 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.2%
15/287 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
13/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.3%
18/287 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
26/288 • Number of events 26 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.0%
20/287 • Number of events 22 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
32/288 • Number of events 34 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
10.5%
30/287 • Number of events 38 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
23/288 • Number of events 27 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 22 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
24/288 • Number of events 24 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
5.2%
15/287 • Number of events 15 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
18/288 • Number of events 18 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
7.3%
21/287 • Number of events 23 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Hypertension
|
18.4%
53/288 • Number of events 57 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
17.4%
50/287 • Number of events 53 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Hypotension
|
14.2%
41/288 • Number of events 44 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
15.7%
45/287 • Number of events 51 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
|
Vascular disorders
Orthostatic hypotension
|
4.5%
13/288 • Number of events 14 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
6.6%
19/287 • Number of events 20 • From first dose of study drug up to 7 days after last dose of study drug (up to 2 years)
The SAF consisted of all participants who enrolled into the study and took at least 1 dose of study medication and was used for all safety, tolerability, and medication compliance related variables.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc. (APGD)
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER