Trial Outcomes & Findings for Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients (NCT NCT03744910)
NCT ID: NCT03744910
Last Updated: 2025-07-23
Results Overview
This primary outcome measure was the one from the first interim analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
194 participants
Primary outcome timeframe
From Baseline to Week 52
Results posted on
2025-07-23
Participant Flow
The study was conducted at 139 study sites in 13 countries: Canada, United States, Austria, Czechia, France, Germany, Hungary, Netherlands, Spain, Sweden, Switzerland, Democratic People's Republic of Korea, and Australia.
A total of 382 participants were screened, of which 188 were screen failures. Of the screened participants, 194 were randomized in a 1:1 ratio to receive study interventions (Clazakizumab or Placebo).
Participant milestones
| Measure |
Clazakizumab
Participants received clazakizumab via subcutaneous (SC) injection once every 4 weeks (Q4W) until the participant: permanently discontinued the investigational product (IP), withdrew from the study, experienced allograft loss, died, or reached the common treatment end date (CTED), whichever occurred first during this study.
|
Placebo
Participants received Placebo by SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
100
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
78
|
85
|
Reasons for withdrawal
| Measure |
Clazakizumab
Participants received clazakizumab via subcutaneous (SC) injection once every 4 weeks (Q4W) until the participant: permanently discontinued the investigational product (IP), withdrew from the study, experienced allograft loss, died, or reached the common treatment end date (CTED), whichever occurred first during this study.
|
Placebo
Participants received Placebo by SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
1
|
8
|
|
Overall Study
Physician Decision
|
5
|
4
|
|
Overall Study
Sponsor Decision (due to study termination)
|
68
|
71
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other-unspecified
|
4
|
1
|
Baseline Characteristics
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Clazakizumab
n=94 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 12.24 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic, Latino/a or of Spanish origin
|
69 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic, Latino/a or of Spanish origin
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
62 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Korean
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian Indian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Filipino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 52Population: Analysis was performed on the intent-to-treat (ITT) analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
This primary outcome measure was the one from the first interim analysis.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR)
|
-8.0 milliliter per minute per 1.73 meter^2
Interval -10.2 to -5.8
|
-5.2 milliliter per minute per 1.73 meter^2
Interval -7.4 to -3.1
|
PRIMARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components: * eGFR \< 15 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2)\* * return to dialysis\* * allograft nephrectomy * retransplantation * death from any cause, or * a sustained (greater than or equal to \[\>=\] 60 days) 40% decline in eGFR from Baseline. (\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The number of participants with composite all-cause allograft loss or irreversible loss of allograft function are reported here. Time-to-event data were not calculated due to the study's termination.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function
|
26 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components: * eGFR \< 15 mL/min/1.73 m\^2\* * return to dialysis\* * allograft nephrectomy * retransplantation * death from any cause, or * a sustained (greater than or equal to \[\>=\] 60 days) 40% decline in eGFR from Baseline. (\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The percentage of participants with composite all-cause allograft loss or irreversible loss of allograft function are reported here.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function
|
28.3 percentage of participants
|
22.2 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Analysis was performed on the safety analysis set (SAS). The SAS consisted of all randomized participants who had received at least 1 dose of study drug.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)
TEAEs
|
89 Participants
|
88 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)
Serious TEAEs
|
39 Participants
|
39 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)
AESIs
|
56 Participants
|
52 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With TEAEs, Serious TEAEs, and AESIs
AESIs
|
60.2 percentage of participants
|
52.0 percentage of participants
|
|
Percentage of Participants With TEAEs, Serious TEAEs, and AESIs
TEAEs
|
95.7 percentage of participants
|
88.0 percentage of participants
|
|
Percentage of Participants With TEAEs, Serious TEAEs, and AESIs
Serious TEAEs
|
41.9 percentage of participants
|
39.0 percentage of participants
|
PRIMARY outcome
Timeframe: From baseline up to 4 yearsPopulation: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'number analyzed' = participants with available data for each specified category.
Number of participants who tested positive for BKV, CMV or EBV according to the maximum measured viral amount (International Units/mL \[IU/mL\]) after baseline are reported here.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
BKV >Lower limit of quantification (LLOQ) to <320 IU/mL
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
BKV >=320 IU/mL to <3200 IU/mL
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
BKV >=3200 IU/mL
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
CMV >LLOQ to <1000 IU/mL
|
5 Participants
|
1 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
CMV >=1000 IU/mL to <5000 IU/mL
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
CMV >=5000 IU/mL
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
EBV >LLOQ to <10200 IU/mL
|
8 Participants
|
7 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
EBV >=10200 IU/mL to <20400 IU/mL
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
EBV >=20400 IU/mL
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants analyzed' = participants with evaluable data for this outcome measure.
Laboratory tests included liver function test (LFTs), complete blood count (CBC), plasma lipids, high-sensitivity C-reactive protein (hsCRP). Only participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Abnormal Laboratory Test Results
ALT : > 3 to 5 × ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
AST : >ULN to 3 x ULN
|
11 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
AST : > 3 to 5 × ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
AST : > 5 × ULN
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Bilirubin: > ULN to 2 × ULN
|
20 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Bilirubin: > 2 × ULN
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Neutrophils: < 2.5 to 1.5 10^9/L
|
33 Participants
|
21 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Neutrophils: < 1.5 to 1.0 10^9/L
|
15 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Neutrophils: < 1.0 10^9/L
|
7 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Platelets: < LLN to 75.0 10^9/L
|
39 Participants
|
10 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
Platelets: < 75.0 to 50.0 10^9/L
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Test Results
ALT : >ULN to 3 x ULN
|
15 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants analyzed' = participants with evaluable data for this outcome measure.
Laboratory tests included LFTs, CBC, plasma lipids, hsCRP. Only percentage of participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With Abnormal Laboratory Test Results
ALT : >ULN to 3 x ULN
|
16.1 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
ALT : > 3 to 5 × ULN
|
0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
AST : >ULN to 3 x ULN
|
11.8 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
AST : > 3 to 5 × ULN
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
AST : > 5 × ULN
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Bilirubin: > ULN to 2 × ULN
|
21.5 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Bilirubin: > 2 × ULN
|
5.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Neutrophils: < 1.5 to 1.0 10^9/L
|
16.1 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Neutrophils: < 1.0 10^9/L
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Neutrophils: < 2.5 to 1.5 10^9/L
|
35.5 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Platelets: < LLN to 75.0 10^9/L
|
41.9 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Test Results
Platelets: < 75.0 to 50.0 10^9/L
|
1.1 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Signs, Electrocardiograms (ECGs), and Physical Examination
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 12, 24, and 48Population: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
Outcome measures
| Measure |
Clazakizumab
n=88 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=97 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies
Baseline
|
5 Participants
|
10 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies
Week 12
|
3 Participants
|
8 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies
Week 24
|
2 Participants
|
7 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies
Week 48
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 12, 24, and 48Population: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
Outcome measures
| Measure |
Clazakizumab
n=88 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=97 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With Positive Anti-drug Antibodies
Baseline
|
5.7 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants With Positive Anti-drug Antibodies
Week 12
|
4.1 percentage of participants
|
9.8 percentage of participants
|
|
Percentage of Participants With Positive Anti-drug Antibodies
Week 24
|
2.9 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants With Positive Anti-drug Antibodies
Week 48
|
0 percentage of participants
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components: * eGFR \< 15 mL/min/1.73 m\^2\* * return to dialysis\* * allograft nephrectomy * retransplantation, or * death from any cause. (\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The number of participants with composite all-cause allograft loss are reported here.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Composite All-cause Allograft Loss
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components: * eGFR \< 15 mL/min/1.73 m\^2\* * return to dialysis\* * allograft nephrectomy * retransplantation, or * death from any cause. (\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The percentage of participants with composite all-cause allograft loss are reported here.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With Composite All-cause Allograft Loss
|
18.5 percentage of participants
|
14.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Irreversible loss of allograft function as defined by a 40% decline in eGFR from Baseline sustained for at least 60 days.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Irreversible Loss of Allograft Function
|
22 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Irreversible loss of allograft function as defined by a 40% decline in eGFR from Baseline sustained for at least 60 days.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With Irreversible Loss of Allograft Function
|
23.9 percentage of participants
|
18.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Time to death-censored allograft loss, was defined as occurrence of any of the following components: * eGFR \< 15 mL/min/1.73 m\^2\* * return to dialysis\* * allograft nephrectomy, or * retransplantation. (\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The number of participants with death-censored allograft loss are reported here.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Number of Participants With Death-censored Allograft Loss
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 4 yearsPopulation: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of the investigational product, had a Baseline assessment, and had at least 1 post-baseline assessment of eGFR.
Death-censored allograft loss was defined as the occurrence of any of the following components: * eGFR \< 15 mL/min/1.73 m\^2\* * return to dialysis\* * allograft nephrectomy, or * retransplantation. (\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The percentage of participants who experienced death-censored allograft loss are reported here.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percentage of Participants With Death-censored Allograft Loss
|
17.4 percentage of participants
|
13.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Outcome measures
| Measure |
Clazakizumab
n=83 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=88 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Change From Baseline in Urine Albumin Creatinine Ratio (UACR)
|
50.734 gram per mole
Standard Deviation 125.5628
|
31.178 gram per mole
Standard Deviation 112.8894
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Analysis was performed on the SAS. The SAS consisted of all randomized participants who had received at least 1 dose of study drug. The Overall Number of Participants Analyzed reported here reflects all participants who were analyzed, which includes all (N = 93 Clazakizumab and 100 Placebo) participants assessed at baseline to determine DSA class I or II. Here, 'Number Analyzed' = the number of participants in Class I or II classified at baseline who had available MFI data at Week 52.
Outcome measures
| Measure |
Clazakizumab
n=93 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Percent Change From Baseline in Mean Fluorescent Intensity for Donor-Specific Antibodies (DSA)
DSA Class I
|
-23.20 percent change
Interval -53.34 to -4.54
|
-39.71 percent change
Interval -69.67 to -20.22
|
|
Percent Change From Baseline in Mean Fluorescent Intensity for Donor-Specific Antibodies (DSA)
DSA Class II
|
-27.15 percent change
Interval -46.32 to -5.05
|
-13.68 percent change
Interval -26.69 to -1.75
|
SECONDARY outcome
Timeframe: From Baseline to Week 52Population: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of the investigational product, had a Baseline assessment, and had at least 1 post-baseline assessment of eGFR.
Banff lesion grading scores assess the presence and the degree of histopathological changes in the different compartments of kidney biopsies. Here, the improved category is defined as a decline in the Banff lesion grading score. Participants with improved scores, not improved scores, and missing biopsies for C4d staining, interstitial fibrosis, tubular atrophy, glomerular basement membrane double contours, glomerulitis and peritubular capillaritis are reported for this outcome measure.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Interstitial Fibrosis · Improved score
|
3 Participants
|
8 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Interstitial Fibrosis · Not improved score
|
24 Participants
|
23 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Glomerulitis · Improved score
|
14 Participants
|
17 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Glomerulitis · Not improved score
|
13 Participants
|
14 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Glomerulitis · Missing biopsies
|
65 Participants
|
68 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Peritubular Capillaritis · Improved score
|
14 Participants
|
15 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Peritubular Capillaritis · Not improved score
|
13 Participants
|
16 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Peritubular Capillaritis · Missing biopsies
|
65 Participants
|
68 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Interstitial Fibrosis · Missing biopsies
|
65 Participants
|
68 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Tubular Atrophy · Improved score
|
1 Participants
|
5 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Tubular Atrophy · Not improved score
|
26 Participants
|
26 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Tubular Atrophy · Missing biopsies
|
65 Participants
|
68 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Glomerular Basement Membrane Double Contours · Improved score
|
6 Participants
|
10 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Glomerular Basement Membrane Double Contours · Not improved score
|
21 Participants
|
21 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
Glomerular Basement Membrane Double Contours · Missing biopsies
|
65 Participants
|
68 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
C4d Staining · Improved score
|
10 Participants
|
10 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
C4d Staining · Not improved score
|
17 Participants
|
21 Participants
|
|
Change From Baseline in Banff Lesion Grading Score (2015 Criteria) of Pre-treatment to Post-treatment (Week 52) Kidney Biopsies
C4d Staining · Missing biopsies
|
65 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Baseline up to End of treatment (up to approximately 4 years)Population: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of study drug and who had a baseline assessment and at least 1 post baseline assessment of eGFR.
Number of participants who had at least one acute rejection episode (TCMR or ABMR) are reported for this outcome measure.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Incidence of Acute Rejection Episodes of T Cell-mediated Rejection (TCMR) and Antibody-mediated Rejection (ABMR)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Analysis was performed on the ITT analysis set. The ITT analysis set consisted of all randomized participants who received at least 1 dose of the investigational product, had a Baseline assessment, and had at least 1 post-baseline assessment of eGFR.
Number of participants who were alive up to Week 52 are reported for this outcome measure.
Outcome measures
| Measure |
Clazakizumab
n=92 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=99 Participants
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Overall Participant Survival
|
90 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Analysis was performed on the PK/ PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure.
A subset of participants (out of the enrolled participants in the main study) had the option to participate in a pharmacokinetic (PK)/ Pharmacodynamic (PD) sub-study.
Outcome measures
| Measure |
Clazakizumab
n=3 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Maximum Concentration at Steady State (Cmax ss) of CSL300
|
3556.8 nanograms per milliliter
Geometric Coefficient of Variation 10.5
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Analysis was performed on the PK/PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure.
A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study.
Outcome measures
| Measure |
Clazakizumab
n=3 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Trough Concentrations at Steady State (Ctrough ss) of CSL300
|
2366.8 nanograms per milliliter
Geometric Coefficient of Variation 9.2
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Analysis was performed on the PK/PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure.
A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study.
Outcome measures
| Measure |
Clazakizumab
n=3 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Area Under the Concentration-time Curve (AUC0-tau) at Steady State of CSL300
|
78080.34636 days*nanograms per milliliter
Geometric Coefficient of Variation 7.19614
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Analysis was performed on the PK/PD analysis set. The PK/PD substudy analysis set consisted of all participants in the SAS who consented to be a part of the PK / PD substudy and had at least 1 quantifiable PK concentration of investigational product after administration. Here, "overall number of participants analyzed' = participants with available data for this outcome measure.
A subset of participants (out of the enrolled participants in the main study) had the option to participate in a PK/PD sub-study.
Outcome measures
| Measure |
Clazakizumab
n=3 Participants
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Time of Maximum Concentration at Steady State (Tmax ss) of CSL300
|
6.92292 day
Interval 4.9986 to 11.9299
|
—
|
Adverse Events
Clazakizumab
Serious events: 39 serious events
Other events: 81 other events
Deaths: 3 deaths
Placebo
Serious events: 39 serious events
Other events: 80 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Clazakizumab
n=93 participants at risk
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 participants at risk
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
14.0%
13/93 • Number of events 15 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
10.0%
10/100 • Number of events 12 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
3.2%
3/93 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.2%
2/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Clostridium difficile infection
|
2.2%
2/93 • Number of events 4 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
2/93 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Influenza
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Arteriovenous graft site infection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Bacteriuria
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Diverticulitis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Escherichia sepsis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis norovirus
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Pseudomonas infection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Pyelonephriti
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Syphilis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Systemic candida
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Urosepsis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Viral diarrhoea
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Viral infection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.0%
13/93 • Number of events 15 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Renal impairment
|
2.2%
2/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
End stage renal disease
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
4/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
3.0%
3/100 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Terminal ileitis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Complications of transplanted pancreas
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
3/93 • Number of events 4 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphatic obstruction
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
2/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.1%
1/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Immune system disorders
Transplant rejection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Immune system disorders
Chronic allograft nephropathy
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Epilepsy
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
General disorders
Chest pain
|
2.2%
2/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
General disorders
Pyrexia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
General disorders
Asthenia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
2/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Troponin increased
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Hypertensive crisis
|
1.1%
1/93 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Angiopathy
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Aortic stenosis
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/93 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Lymphocele
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Venous thrombosis limb
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Immune system disorders
Renal and pancreas transplant rejection
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
Other adverse events
| Measure |
Clazakizumab
n=93 participants at risk
Participants received clazakizumab via SC injection Q4W until the participant: permanently discontinued the IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
Placebo
n=100 participants at risk
Participants received Placebo via SC injection Q4W until the participant: permanently discontinued IP, withdrew from the study, experienced allograft loss, died, or reached the CTED, whichever occurred first during this study.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
30.1%
28/93 • Number of events 31 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
30.0%
30/100 • Number of events 31 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
12.9%
12/93 • Number of events 21 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 9 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
5/93 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
11.0%
11/100 • Number of events 13 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
8/93 • Number of events 8 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
5.0%
5/100 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
6.5%
6/93 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.6%
21/93 • Number of events 24 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
22.0%
22/100 • Number of events 25 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
11/93 • Number of events 13 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
9/93 • Number of events 9 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
7.0%
7/100 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
10/93 • Number of events 12 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
6/93 • Number of events 8 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.4%
5/93 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.9%
12/93 • Number of events 14 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
13.0%
13/100 • Number of events 18 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.2%
2/93 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
9.0%
9/100 • Number of events 11 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.2%
3/93 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
5.0%
5/100 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.5%
7/93 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
3.0%
3/100 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
5.0%
5/100 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.2%
16/93 • Number of events 19 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
16.0%
16/100 • Number of events 17 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.1%
15/93 • Number of events 22 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
8/93 • Number of events 14 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
6/93 • Number of events 8 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
25.8%
24/93 • Number of events 31 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
11.0%
11/100 • Number of events 12 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
General disorders
Fatigue
|
8.6%
8/93 • Number of events 9 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
8.0%
8/100 • Number of events 10 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
General disorders
Asthenia
|
1.1%
1/93 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
5.0%
5/100 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
9.7%
9/93 • Number of events 12 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
13.0%
13/100 • Number of events 15 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Immunosuppressant drug level decreased
|
4.3%
4/93 • Number of events 9 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 10 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Immunosuppressant drug level increased
|
4.3%
4/93 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 10 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Weight decreased
|
3.2%
3/93 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
0.00%
0/100 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.6%
8/93 • Number of events 9 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
5.0%
5/100 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
8.0%
8/100 • Number of events 8 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Renal impairment
|
7.5%
7/93 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
6.0%
6/100 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
6/93 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
4.0%
4/100 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
6/93 • Number of events 6 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
4.0%
4/100 • Number of events 4 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
4.0%
4/100 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
5/93 • Number of events 8 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
8.0%
8/100 • Number of events 12 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.6%
8/93 • Number of events 8 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
2.0%
2/100 • Number of events 2 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Vascular disorders
Hypertension
|
12.9%
12/93 • Number of events 12 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
13.0%
13/100 • Number of events 15 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
10.8%
10/93 • Number of events 14 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
9.0%
9/100 • Number of events 9 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
6.5%
6/93 • Number of events 7 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
3.0%
3/100 • Number of events 3 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
5.4%
5/93 • Number of events 5 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
1.0%
1/100 • Number of events 1 • Up to 4 years
The SAS consisted of all randomized participants who received at least 1 dose of study drug. The participants in the SAS were analyzed according to the actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place