Trial Outcomes & Findings for Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (NCT NCT03663335)
NCT ID: NCT03663335
Last Updated: 2026-03-23
Results Overview
The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
418 participants
Primary outcome timeframe
12 Months
Results posted on
2026-03-23
Participant Flow
Patients were enrolled at 74 sites. 403 patients were randomized.
This study comprised of a screening period
Participant milestones
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids
Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W.
On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose.
At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL \& 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.
|
Arm 2/Cohort 2 (Maintenance Cohort): TAC + MMF ± Corticosteroids
Patients continued to receive the same immunosuppressive regimen (same drugs) as before entering the study. Patients on a once daily TAC formulation could continue with this regimen.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
108
|
109
|
74
|
70
|
42
|
|
Overall Study
Full Analysis Set
|
108
|
109
|
74
|
70
|
42
|
|
Overall Study
Pharmacokinetics Analysis Set
|
110
|
109
|
0
|
70
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
108
|
109
|
74
|
70
|
42
|
Reasons for withdrawal
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids
Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W.
On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose.
At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL \& 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.
|
Arm 2/Cohort 2 (Maintenance Cohort): TAC + MMF ± Corticosteroids
Patients continued to receive the same immunosuppressive regimen (same drugs) as before entering the study. Patients on a once daily TAC formulation could continue with this regimen.
|
|---|---|---|---|---|---|
|
Overall Study
Unsatisfactory therapeutic effect
|
5
|
2
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
8
|
19
|
3
|
6
|
0
|
|
Overall Study
Death
|
9
|
1
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient not continuing after Month12
|
12
|
9
|
11
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Study terminated by Sponsor
|
71
|
73
|
53
|
60
|
33
|
|
Overall Study
Subject decision
|
3
|
5
|
3
|
0
|
4
|
Baseline Characteristics
Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
Baseline characteristics by cohort
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=108 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=109 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
n=74 Participants
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids
n=70 Participants
Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W.
On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose.
At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL \& 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.
|
Arm 2/Cohort 2 (Maintenance Cohort): TAC + MMF ± Corticosteroids
n=42 Participants
Patients continued to receive the same immunosuppressive regimen (same drugs) as before entering the study. Patients on a once daily TAC formulation could continue with this regimen.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
< 60 years
|
86 Participants
n=10 Participants
|
79 Participants
n=8 Participants
|
54 Participants
n=18 Participants
|
53 Participants
n=158 Participants
|
32 Participants
n=3 Participants
|
304 Participants
n=1 Participants
|
|
Age, Customized
>= 60 6years
|
22 Participants
n=10 Participants
|
30 Participants
n=8 Participants
|
20 Participants
n=18 Participants
|
17 Participants
n=158 Participants
|
10 Participants
n=3 Participants
|
99 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=10 Participants
|
32 Participants
n=8 Participants
|
14 Participants
n=18 Participants
|
18 Participants
n=158 Participants
|
14 Participants
n=3 Participants
|
112 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=10 Participants
|
77 Participants
n=8 Participants
|
60 Participants
n=18 Participants
|
52 Participants
n=158 Participants
|
28 Participants
n=3 Participants
|
291 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White
|
84 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
86 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
59 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
47 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
32 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
308 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
6 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
6 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
3 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
4 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
33 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Asian: Indian
|
2 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
3 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Asian: Japanese
|
4 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
12 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
3 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
12 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
4 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
35 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Asian: Korean
|
1 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
3 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
4 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Asian: Other
|
0 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
2 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
5 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
4 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
3 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
2 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
13 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
|
Race/Ethnicity, Customized
Other - Unknown
|
0 Participants
n=10 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=8 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=18 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=158 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
0 Participants
n=3 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
1 Participants
n=1 Participants • Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. The analysis was based on the number of patients with composite efficacy failure up to Month 12 per-protocol central and adjudicated assessment.
The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=66 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=70 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
n=41 Participants
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1)
|
60.6 Percentage of participants
|
38.6 Percentage of participants
|
22.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. The analysis was based on the number of patients with composite efficacy failure up to Month 12 per-protocol central and adjudicated assessment.
The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=34 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=18 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)
|
14.7 Percentage of participants
|
11.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients.
In the de novo population (Cohort 1), the mean eGFR at Month 12 post-transplantation was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=58 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=58 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
n=51 Participants
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Cohort 1: Mean Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-transplantation
|
58.83 mL/min/1.73m^2
Standard Error 1.971
|
60.63 mL/min/1.73m^2
Standard Error 1.976
|
54.12 mL/min/1.73m^2
Standard Error 2.101
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients.
In the maintenance population (Cohort 2), a baseline kidney function and the mean change from baseline at Month 12 post-conversion of eGFR was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=39 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=27 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Cohort 2: Mean Change in Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-conversion
|
4.30 mL/min/1.73m^2
Standard Error 1.722
|
1.42 mL/min/1.73m^2
Standard Error 1.866
|
—
|
SECONDARY outcome
Timeframe: Day 1-Pre-Dose to Month 30-Pre-DosePopulation: Pharmacokinetics analysis set (PK): all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PD, e.g. if a dose was taken more than 7 days after the planned date. The PK analysis set has 2 more patients than the FAS as these patients took study medication but did not undergo transplantation.
Pharmacokinetics were determined for free CFZ533 plasma concentrations during the treatment period.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=110 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=109 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Day 5 pre-dose
|
231.93 µg/mL
Standard Deviation 102.947
|
205.16 µg/mL
Standard Deviation 77.632
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Day 5 post-dose
|
502.48 µg/mL
Standard Deviation 211.592
|
502.32 µg/mL
Standard Deviation 186.159
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Day 15 pre-dose
|
251.17 µg/mL
Standard Deviation 92.466
|
242.99 µg/mL
Standard Deviation 83.780
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Day 29 pre-dose
|
197.47 µg/mL
Standard Deviation 74.937
|
187.38 µg/mL
Standard Deviation 79.884
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 1.5 pre-dose
|
172.84 µg/mL
Standard Deviation 67.444
|
122.80 µg/mL
Standard Deviation 38.604
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 2 pre-dose
|
155.68 µg/mL
Standard Deviation 64.661
|
102.52 µg/mL
Standard Deviation 33.798
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 2.5 pre-dose
|
151.81 µg/mL
Standard Deviation 58.367
|
85.21 µg/mL
Standard Deviation 34.835
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 3 pre-dose
|
147.62 µg/mL
Standard Deviation 51.971
|
86.16 µg/mL
Standard Deviation 35.463
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 4 pre-dose
|
159.58 µg/mL
Standard Deviation 70.382
|
68.72 µg/mL
Standard Deviation 27.269
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 6 pre-dose
|
161.21 µg/mL
Standard Deviation 63.195
|
73.27 µg/mL
Standard Deviation 35.126
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 8 pre-dose
|
151.34 µg/mL
Standard Deviation 52.778
|
71.92 µg/mL
Standard Deviation 33.683
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 10 pre-dose
|
141.18 µg/mL
Standard Deviation 46.999
|
62.55 µg/mL
Standard Deviation 31.199
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Moth 12 pre-dose
|
148.71 µg/mL
Standard Deviation 62.106
|
56.81 µg/mL
Standard Deviation 30.717
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 15 pre-dose
|
149.86 µg/mL
Standard Deviation 58.888
|
48.37 µg/mL
Standard Deviation 20.604
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 18 pre-dose
|
122.24 µg/mL
Standard Deviation 54.056
|
49.68 µg/mL
Standard Deviation 31.768
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 21 pre-dose
|
132.51 µg/mL
Standard Deviation 65.146
|
59.96 µg/mL
Standard Deviation 36.583
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 24 pre-dose
|
139.55 µg/mL
Standard Deviation 53.177
|
60.96 µg/mL
Standard Deviation 31.988
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Month 30 pre-dose
|
140.80 µg/mL
Standard Deviation 47.339
|
56.63 µg/mL
Standard Deviation 23.195
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Day 1 Pre-dose
|
0.00 µg/mL
Standard Deviation 0.000
|
0.00 µg/mL
Standard Deviation 0.000
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Day 1 post-dose
|
471.20 µg/mL
Standard Deviation 222.169
|
441.67 µg/mL
Standard Deviation 246.474
|
—
|
SECONDARY outcome
Timeframe: Day 1-Pre-Dose to Month 30-Pre-DosePopulation: Pharmacokinetics analysis set (PK): all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PD, e.g. if a dose was taken more than 7 days after the planned date.
Pharmacokinetics were determined for free CFZ533 plasma concentrations during the treatment period.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=70 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Day 1 Pre-dose
|
0.00 µg/mL
Standard Deviation 0.000
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Day 1 post-dose
|
681.59 µg/mL
Standard Deviation 698.086
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Day 15 pre-dose
|
181.81 µg/mL
Standard Deviation 72.297
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Day 29 pre-dose
|
147.56 µg/mL
Standard Deviation 43.749
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 1.5 pre-dose
|
127.55 µg/mL
Standard Deviation 39.794
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 2 pre-dose
|
121.81 µg/mL
Standard Deviation 44.801
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 2.5 pre-dose
|
114.53 µg/mL
Standard Deviation 44.759
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 3 pre-dose
|
104.40 µg/mL
Standard Deviation 42.563
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 4 pre-dose
|
108.61 µg/mL
Standard Deviation 51.790
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 6 pre-dose
|
112.14 µg/mL
Standard Deviation 46.932
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 8 pre-dose
|
118.08 µg/mL
Standard Deviation 42.868
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 10 pre-dose
|
106.98 µg/mL
Standard Deviation 53.798
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Moth 12 pre-dose
|
111.05 µg/mL
Standard Deviation 54.629
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 15 pre-dose
|
104.11 µg/mL
Standard Deviation 67.744
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 18 pre-dose
|
115.59 µg/mL
Standard Deviation 66.227
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 21 pre-dose
|
116.89 µg/mL
Standard Deviation 53.953
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 24 pre-dose
|
111.03 µg/mL
Standard Deviation 39.901
|
—
|
—
|
|
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Month 30 pre-dose
|
132.97 µg/mL
Standard Deviation 65.132
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Pharmacokinetics analysis set (PK): all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PD, e.g. if a dose was taken more than 7 days after the planned date. The PK analysis set has 2 more patients than the FAS as these patients took study medication but did not undergo transplantation.
The presence of anti-CFZ533 antibodies was assessed using screening and confirmatory assays.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=110 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=109 Participants
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Subject with an on-study result
|
109 Participants
|
108 Participants
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Binding antibody positive at any time
|
2 Participants
|
0 Participants
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Subject with a result at baseline
|
104 Participants
|
101 Participants
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Binding antibody positive at or before baseline
|
0 Participants
|
0 Participants
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Subject with a post-baseline result
|
102 Participants
|
103 Participants
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Binding antibody positive post-baseline with a positive result at baseline
|
0 Participants
|
0 Participants
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Binding antibody positive post-baseline with a negative result at baseline
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Pharmacokinetics analysis set (PK): all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PD, e.g. if a dose was taken more than 7 days after the planned date.
The presence of anti-CFZ533 antibodies was assessed using screening and confirmatory assays.
Outcome measures
| Measure |
Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
n=70 Participants
Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
|
Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids
Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
|
Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids
Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
|
|---|---|---|---|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Subject with an on-study result
|
70 Participants
|
—
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Binding antibody positive at any time
|
0 Participants
|
—
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Subject with a result at baseline
|
68 Participants
|
—
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Binding antibody positive at or before baseline
|
0 Participants
|
—
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Subject with a post-baseline result
|
69 Participants
|
—
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Binding antibody positive post-baseline with a positive result at baseline
|
0 Participants
|
—
|
—
|
|
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Binding antibody positive post-baseline with a negative or no result at baseline
|
0 Participants
|
—
|
—
|
Adverse Events
Pre-treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
De Novo Cohort: CFZ533 600 mg + MMF + CS/On-treatment Period
Serious events: 71 serious events
Other events: 105 other events
Deaths: 2 deaths
De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Safety Follow-up Period
Serious events: 18 serious events
Other events: 20 other events
Deaths: 5 deaths
De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Survival Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
De Novo Cohort: CFZ533 300 mg + MMF + CS/On-treatment Period
Serious events: 76 serious events
Other events: 102 other events
Deaths: 0 deaths
De Novo Cohort: CFZ533 300 mg + MMF + CS/Post-treatment Safety Follow-up Period
Serious events: 19 serious events
Other events: 19 other events
Deaths: 1 deaths
De Novo Cohort: CFZ533 300 mg + MMF + CS/Post- Treatment Survival Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
De Novo Cohort: TAC + MMF + CS/On-treatment Period
Serious events: 39 serious events
Other events: 67 other events
Deaths: 1 deaths
De Novo Cohort: TAC + MMF + CS/Post-treatment Safety Follow-up Period
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
De Novo Cohort: TAC + MMF + CS/Post- Treatment Survival Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/On-treatment Period
Serious events: 25 serious events
Other events: 54 other events
Deaths: 0 deaths
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post-treatment Safety Follow-up Period
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post- Treatment Survival Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maintenance Cohort: TAC + MMF +/- CS/On-treatment Period
Serious events: 11 serious events
Other events: 26 other events
Deaths: 1 deaths
Maintenance Cohort: TAC + MMF +/- CS/Post-treatment Safety Follow-up Period
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Maintenance Cohort: TAC + MMF +/- CS/Post- Treatment Survival Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-treatment
from randomization until first treatment to report pre-treatment mortalities
|
De Novo Cohort: CFZ533 600 mg + MMF + CS/On-treatment Period
n=108 participants at risk
From first dose up to 14 days after last dose of CFZ533
|
De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Safety Follow-up Period
n=108 participants at risk
From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.
|
De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
De Novo Cohort: CFZ533 300 mg + MMF + CS/On-treatment Period
n=109 participants at risk
From first dose up to 14 days after last dose of CFZ533
|
De Novo Cohort: CFZ533 300 mg + MMF + CS/Post-treatment Safety Follow-up Period
n=109 participants at risk
From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.
|
De Novo Cohort: CFZ533 300 mg + MMF + CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
De Novo Cohort: TAC + MMF + CS/On-treatment Period
n=73 participants at risk
From 1st dose to last dose of TAC
|
De Novo Cohort: TAC + MMF + CS/Post-treatment Safety Follow-up Period
n=73 participants at risk
From day 1 after last dose of TAC till completion of the 12 weeks safety follow up. Note: patients may have switched to Standard of care.
|
De Novo Cohort: TAC + MMF + CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/On-treatment Period
n=70 participants at risk
From first dose up to 14 days after last dose of CFZ533
|
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post-treatment Safety Follow-up Period
n=70 participants at risk
From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.
|
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
Maintenance Cohort: TAC + MMF +/- CS/On-treatment Period
n=42 participants at risk
From 1st dose to last dose of TAC
|
Maintenance Cohort: TAC + MMF +/- CS/Post-treatment Safety Follow-up Period
n=42 participants at risk
From day 1 after last dose of TAC till completion of the 12 weeks safety follow up. Note: patients may have switched to Standard of care.
|
Maintenance Cohort: TAC + MMF +/- CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Acute coronary syndrome
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Acute myocardial infarction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Angina unstable
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Cardiac failure
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Myocardial infarction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Myocardial ischaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Endocrine disorders
Adrenal insufficiency
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Endocrine disorders
Goitre
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Endocrine disorders
Hyperaldosteronism
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Endocrine disorders
Hyperparathyroidism
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Eye disorders
Photophobia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Eye disorders
Retinal detachment
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Eye disorders
Uveitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Ascites
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Colitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Enteritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Food poisoning
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Ileus
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Inguinal hernia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Large intestine perforation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Stomatitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Asthenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Chest pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Chills
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Fatigue
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
General physical health deterioration
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Hernia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Hyperthermia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Inflammation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Pyrexia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
COVID-19 pneumonia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Weight decreased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Immune system disorders
Transplant rejection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.8%
16/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.2%
10/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.2%
6/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Adenovirus infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
BK virus infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Bacteraemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Bronchitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
COVID-19
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.1%
3/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Campylobacter infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Candida infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cellulitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Clostridium difficile colitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Clostridium difficile infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cryptococcal meningoencephalitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus colitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus gastritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.8%
16/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.1%
11/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Diarrhoea infectious
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Diverticulitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Escherichia sepsis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Gastroenteritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Gastroenteritis viral
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Herpes zoster
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Infected lymphocele
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Influenza
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Localised infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Necrotising fasciitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Oral candidiasis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Parotitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Parvovirus B19 infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pneumonia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pneumonia legionella
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Postoperative wound infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Prostatitis Escherichia coli
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pyelonephritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pyelonephritis acute
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Renal abscess
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Respiratory tract infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Rhinitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Sepsis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Septic shock
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Suspected COVID-19
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Toxoplasmosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.2%
6/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
5/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urinary tract infection bacterial
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urosepsis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Wound infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Seizure
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Graft ischaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Graft complication
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Graft loss
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood creatinine increased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Postoperative lymphocele
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Procedural shock
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Haematoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood glucose increased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Troponin increased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Anosmia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Cerebrovascular accident
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Ischaemic neuropathy
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Mononeuropathy multiplex
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Quadrantanopia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Radiculitis brachial
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Product Issues
Device dislocation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.6%
7/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Calculus urinary
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Dysuria
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Glomerulonephritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Haematuria
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Perinephric collection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal artery stenosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal cyst
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal impairment
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal infarct
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal ischaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Ureteric stenosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Urinary fistula
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Urinary incontinence
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Urinary tract disorder
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Prostatitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Arterial stenosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Arterial thrombosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Arteriosclerosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Deep vein thrombosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Hypotension
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Iliac artery stenosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Lymphocele
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Peripheral artery stenosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Shock
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Shock haemorrhagic
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Subclavian artery stenosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Varicose ulceration
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Venous thrombosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Cardiac disorders
Angina pectoris
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Malaise
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Device related infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Gastrointestinal infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
H1N1 influenza
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Leishmaniasis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pneumonia viral
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Pseudomonas infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Tuberculosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood creatine increased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Clostridium test positive
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Syncope
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Hydronephrosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Urethral obstruction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Infarction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
Other adverse events
| Measure |
Pre-treatment
from randomization until first treatment to report pre-treatment mortalities
|
De Novo Cohort: CFZ533 600 mg + MMF + CS/On-treatment Period
n=108 participants at risk
From first dose up to 14 days after last dose of CFZ533
|
De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Safety Follow-up Period
n=108 participants at risk
From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.
|
De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
De Novo Cohort: CFZ533 300 mg + MMF + CS/On-treatment Period
n=109 participants at risk
From first dose up to 14 days after last dose of CFZ533
|
De Novo Cohort: CFZ533 300 mg + MMF + CS/Post-treatment Safety Follow-up Period
n=109 participants at risk
From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.
|
De Novo Cohort: CFZ533 300 mg + MMF + CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
De Novo Cohort: TAC + MMF + CS/On-treatment Period
n=73 participants at risk
From 1st dose to last dose of TAC
|
De Novo Cohort: TAC + MMF + CS/Post-treatment Safety Follow-up Period
n=73 participants at risk
From day 1 after last dose of TAC till completion of the 12 weeks safety follow up. Note: patients may have switched to Standard of care.
|
De Novo Cohort: TAC + MMF + CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/On-treatment Period
n=70 participants at risk
From first dose up to 14 days after last dose of CFZ533
|
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post-treatment Safety Follow-up Period
n=70 participants at risk
From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.
|
Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
Maintenance Cohort: TAC + MMF +/- CS/On-treatment Period
n=42 participants at risk
From 1st dose to last dose of TAC
|
Maintenance Cohort: TAC + MMF +/- CS/Post-treatment Safety Follow-up Period
n=42 participants at risk
From day 1 after last dose of TAC till completion of the 12 weeks safety follow up. Note: patients may have switched to Standard of care.
|
Maintenance Cohort: TAC + MMF +/- CS/Post- Treatment Survival Follow-up Period
After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
33.3%
36/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
21.1%
23/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
16.4%
12/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.1%
3/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Leukopenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
28.7%
31/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
28.4%
31/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
21.9%
16/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.9%
9/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
13.0%
14/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.7%
16/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.3%
9/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.9%
13/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
7/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.4%
8/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.2%
10/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.2%
6/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
27.8%
30/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
19.3%
21/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
16.4%
12/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
17.6%
19/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
22.9%
25/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
27.4%
20/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.7%
11/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
4/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.0%
13/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.9%
13/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.1%
11/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
4/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.1%
12/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.2%
10/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.6%
7/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Asthenia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Fatigue
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.3%
10/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Oedema peripheral
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
19.4%
21/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.9%
13/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.6%
7/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
General disorders
Pyrexia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
18.5%
20/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.6%
17/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.0%
7/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
4/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
BK virus infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.0%
13/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.1%
11/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.3%
9/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Bronchitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.5%
7/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
COVID-19
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.3%
9/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.6%
7/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
4/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Cytomegalovirus infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
13.9%
15/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.3%
8/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.0%
8/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Gastroenteritis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.1%
3/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Herpes zoster
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Nasopharyngitis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.4%
8/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
5/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Oral herpes
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.5%
7/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.7%
4/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.4%
8/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
17.6%
19/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
24.8%
27/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
23.3%
17/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
5/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.5%
7/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.3%
8/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.0%
13/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
17.4%
19/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.4%
8/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Blood creatinine increased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Cytomegalovirus test positive
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.3%
10/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.0%
13/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Investigations
SARS-CoV-2 test negative
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.1%
3/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Acidosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Gout
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.1%
12/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
14.7%
16/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
23.3%
17/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
16.7%
18/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.3%
8/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
24.7%
18/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
13.7%
10/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
19.4%
21/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.9%
13/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.1%
3/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.5%
7/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.1%
12/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
12.8%
14/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.6%
7/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.2%
6/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.3%
9/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.3%
3/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
13.9%
15/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.1%
11/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.0%
8/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.6%
6/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
4/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Nervous system disorders
Tremor
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
15.1%
11/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.3%
9/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.3%
8/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.6%
7/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
7.1%
3/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Dysuria
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.1%
11/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.0%
8/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Haematuria
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Perinephric collection
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Proteinuria
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.6%
6/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Renal and urinary disorders
Renal impairment
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
6/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
10.2%
11/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.6%
6/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
8.3%
9/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.8%
2/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.3%
10/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.7%
2/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
9.5%
4/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.92%
1/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.6%
6/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.8%
2/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.9%
2/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Haematoma
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.8%
3/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
5.5%
4/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Hypertension
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
33.3%
36/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.93%
1/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
26.6%
29/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
20.5%
15/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
17.1%
12/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
2.4%
1/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Hypotension
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
11.1%
12/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.9%
2/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
4.6%
5/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.8%
5/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
1.4%
1/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
|
Vascular disorders
Lymphocele
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
3.7%
4/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/108 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
6.4%
7/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/109 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/73 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/70 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
0.00%
0/42 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
—
0/0 • Deaths were reported from randomization until end of study, up to approx. 2.9 years. Adverse Events were reported from first dose of study treatment until end of safety follow-up (14 weeks safety follow-up CFZ533 and 12 weeks safety follow-up for TAC) up to approx. 2.9 years.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER