Trial Outcomes & Findings for A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation (NCT NCT06365437)
NCT ID: NCT06365437
Last Updated: 2026-03-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
12 months
Results posted on
2026-03-12
Participant Flow
Participant milestones
| Measure |
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
8
|
8
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
7
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
8
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
Baseline characteristics by cohort
| Measure |
Arm 1
n=6 Participants
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 Participants
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=9 Participants
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 4
n=8 Participants
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
n=5 Participants
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.8 Years
STANDARD_DEVIATION 7.76 • n=6 Participants
|
52.2 Years
STANDARD_DEVIATION 15.37 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 7.13 • n=9 Participants
|
49.5 Years
STANDARD_DEVIATION 12.71 • n=8 Participants
|
48.6 Years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
52 Years
STANDARD_DEVIATION 10.65 • n=33 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
26 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=33 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=33 Participants
|
|
Region of Enrollment
Sweden
|
2 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=33 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=33 Participants
|
|
Height
|
176.33 cm
STANDARD_DEVIATION 11.112 • n=6 Participants
|
177.4 cm
STANDARD_DEVIATION 7.369 • n=5 Participants
|
172.63 cm
STANDARD_DEVIATION 172 • n=9 Participants
|
173.25 cm
STANDARD_DEVIATION 8.828 • n=8 Participants
|
172 cm
STANDARD_DEVIATION 11.79 • n=5 Participants
|
174.44 cm
STANDARD_DEVIATION 9.059 • n=33 Participants
|
|
Weight
|
80.183 Kg
STANDARD_DEVIATION 19.372 • n=6 Participants
|
81.82 Kg
STANDARD_DEVIATION 20.141 • n=5 Participants
|
76.725 Kg
STANDARD_DEVIATION 15.909 • n=9 Participants
|
80.488 Kg
STANDARD_DEVIATION 10.999 • n=8 Participants
|
82.160 Kg
STANDARD_DEVIATION 10.914 • n=5 Participants
|
79.959 Kg
STANDARD_DEVIATION 14.7251 • n=33 Participants
|
|
BMI
|
25.72 kg/m^2
STANDARD_DEVIATION 5.627 • n=6 Participants
|
26 kg/m^2
STANDARD_DEVIATION 6.050 • n=5 Participants
|
25.64 kg/m^2
STANDARD_DEVIATION 4.262 • n=9 Participants
|
26.81 kg/m^2
STANDARD_DEVIATION 2.918 • n=8 Participants
|
27.26 kg/m^2
STANDARD_DEVIATION 3.713 • n=5 Participants
|
26.26 kg/m^2
STANDARD_DEVIATION 4.247 • n=33 Participants
|
|
Viral Serology
Cytomegalovirus · Negative
|
1 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
1 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
3 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
2 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
2 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
9 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Cytomegalovirus · Positive
|
5 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
4 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
6 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
3 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
23 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Epstein-Barr Virus · Negative
|
0 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Epstein-Barr Virus · Positive
|
6 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
32 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
End Stage Disease leading to Transplantation
Hypertension/nephrosclerosis
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=33 Participants
|
|
Viral Serology
Hepatitis C Virus antibody · Negative
|
6 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
32 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Hepatitis C Virus antibody · Positive
|
0 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Hepatitis B surface Antigen · Negative
|
6 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
32 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Hepatitis B surface Antigen · Positive
|
0 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Human Immunodeficiency virus · Negative
|
6 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
8 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
5 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
32 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
Viral Serology
Human Immunodeficiency virus · Positive
|
0 Participants
n=6 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=8 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=5 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
0 Participants
n=32 Participants • Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected.
|
|
End Stage Disease leading to Transplantation
Glomerular Disease
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Polycystic disease
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Diabetes Mellitus
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
IgA nephropathy
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Pyelonephritis
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Drug Induced Toxicity
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Interstitial Nephritis
|
0 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Vasculitis
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Renal Hypoplasia/Dysplasia
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Other
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=33 Participants
|
|
End Stage Disease leading to Transplantation
Unknown
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
|
Current Dialysis
Hemodialysis
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=33 Participants
|
|
Current Dialysis
Peritoneal Dialysis
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=33 Participants
|
|
Current Dialysis
None
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Arm 4
n=8 Participants
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 1
n=6 Participants
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 Participants
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 Participants
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
n=5 Participants
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Medication Discontinuation · Yes
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 Serious Infection · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE Related to Study Medicatoin · Yes
|
8 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE Related to Study Medicatoin · No
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE · Yes
|
4 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE · No
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Discontinuation · Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Discontinuation · No
|
7 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose adjustment · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose adjustment · No
|
8 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose interruption · Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose interruption · No
|
7 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Medication Discontinuation · No
|
6 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 Infection · Yes
|
2 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 Infection · No
|
6 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 Serious Infection · No
|
8 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE related to Study Medication · Yes
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE related to Study Medication · No
|
5 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE · Yes
|
8 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE · No
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants enrolled in Arm 5, Control, are not included in this Outcome Measure because they were not assessed for PK parameters of Siplizumab.
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Outcome measures
| Measure |
Arm 4
n=7 Participants
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 1
n=6 Participants
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 Participants
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 Participants
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.
|
135 ug/mL
Standard Deviation 11.8
|
4.3 ug/mL
Standard Deviation 0.578
|
12.8 ug/mL
Standard Deviation 1.96
|
50.6 ug/mL
Standard Deviation 9.79
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants enrolled in Arm 5, Control, are not included in this Outcome Measure because they were not assessed for PK parameters of Siplizumab.
The AUC from time zero to the last measurable concentration sampling time.
Outcome measures
| Measure |
Arm 4
n=7 Participants
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 1
n=6 Participants
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 Participants
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 Participants
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).
|
1910 ug/mLxday
Standard Deviation 389
|
26.2 ug/mLxday
Standard Deviation 4.67
|
95.4 ug/mLxday
Standard Deviation 29.3
|
627 ug/mLxday
Standard Deviation 249
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Arm 4
n=8 Participants
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 1
n=6 Participants
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 Participants
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 Participants
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
n=5 Participants
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
The Incidence of Allograft Rejection at 12 Months Post-Transplant
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The sponsor made the decision to terminate the clinical trial for non safety-related reasons prior to all Arm 4 Subjects completing Month 12 post-transplant.
Outcome measures
| Measure |
Arm 4
n=8 Participants
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 1
n=6 Participants
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 Participants
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 Participants
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
n=5 Participants
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
To Assess Renal Function Over Time
Month 12
|
—
|
45.15 mL/min/1.73m^2
Standard Deviation 9.295
|
70.06 mL/min/1.73m^2
Standard Deviation 16.051
|
56.96 mL/min/1.73m^2
Standard Deviation 8.411
|
61.23 mL/min/1.73m^2
Standard Deviation 9.02
|
|
To Assess Renal Function Over Time
Baseline
|
59.45 mL/min/1.73m^2
Standard Deviation 12.676
|
32.99 mL/min/1.73m^2
Standard Deviation 15.671
|
61.8 mL/min/1.73m^2
Standard Deviation 20.521
|
51.85 mL/min/1.73m^2
Standard Deviation 12.011
|
51.17 mL/min/1.73m^2
Standard Deviation 8.376
|
|
To Assess Renal Function Over Time
Month 3
|
57.92 mL/min/1.73m^2
Standard Deviation 9.412
|
40.51 mL/min/1.73m^2
Standard Deviation 14.339
|
67.11 mL/min/1.73m^2
Standard Deviation 21.028
|
52.53 mL/min/1.73m^2
Standard Deviation 9.416
|
53.48 mL/min/1.73m^2
Standard Deviation 4.918
|
|
To Assess Renal Function Over Time
Month 6
|
54.64 mL/min/1.73m^2
Standard Deviation 21.590
|
37.98 mL/min/1.73m^2
Standard Deviation 8.236
|
64.75 mL/min/1.73m^2
Standard Deviation 11.501
|
52.64 mL/min/1.73m^2
Standard Deviation 8.727
|
58.93 mL/min/1.73m^2
Standard Deviation 4.918
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 3
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 4
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 5
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=6 participants at risk
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 participants at risk
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 participants at risk
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 4
n=8 participants at risk
TCD601 5.0mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
n=5 participants at risk
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Pulmonary Nocardiosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Pneuomonia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Cerebral Nocardiosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Delayed Graft Function
|
33.3%
2/6 • Number of events 2 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Graft Thrombosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Renal Lymphocele
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Metabolism and nutrition disorders
New onset Diabetes after transplantation
|
16.7%
1/6 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Immune system disorders
Transplant Rejection
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Focal Segmental Glomerulosclerosis
|
16.7%
1/6 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Renal Impairment
|
16.7%
1/6 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Vascular disorders
Lymphocele
|
16.7%
1/6 • Number of events 1 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
Other adverse events
| Measure |
Arm 1
n=6 participants at risk
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 2
n=5 participants at risk
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 3
n=8 participants at risk
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 4
n=8 participants at risk
TCD601 5.0mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
Arm 5
n=5 participants at risk
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
|
|---|---|---|---|---|---|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Eye disorders
scleral hemorrhage
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
BK virus infection
|
50.0%
3/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Bacteriuria
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Cytomegalovirus infection
|
16.7%
1/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Cytomegalovirus viraemia
|
50.0%
3/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
62.5%
5/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Device related infection
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Genital herpes
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Lyme disease
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
3/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
37.5%
3/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Oral candidiasis
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Oral herpes
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Polyomavirus viraemia
|
66.7%
4/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Tooth infection
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Transmission of an infectious agent via product
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Anti factor VIII antibody increased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6 • 12 Months
|
40.0%
2/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • 12 Months
|
40.0%
2/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Blood urea increased
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Blood uric acid increased
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Epstein-Barr virus antibody positive
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hepatic enzyme increased
|
33.3%
2/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Renal function test abnormal
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Acidosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Diabetes mellitus
|
33.3%
2/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Fluid retention
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Folate deficiency
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Glucose tolerance impaired
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypercalcaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Hypercholesterolaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Hyperglycaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hyperkalaemia
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
50.0%
4/8 • 12 Months
|
25.0%
2/8 • 12 Months
|
40.0%
2/5 • 12 Months
|
|
Investigations
Hyperlipasaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Hyperlipidaemia
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypernatraemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Hyperphosphataemia
|
33.3%
2/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hyperuricaemia
|
33.3%
2/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypocalcaemia
|
33.3%
2/6 • 12 Months
|
40.0%
2/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypokalaemia
|
16.7%
1/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypomagnesaemia
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hyponatraemia
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypophosphataemia
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
37.5%
3/8 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Hypoproteinaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Investigations
Metabolic acidosis
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
New onset diabetes after transplantation
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Investigations
Obesity
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Dysaesthesia
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Nervous system disorders
Tremor
|
33.3%
2/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Psychiatric disorders
Adjustment disorder
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Psychiatric disorders
Restlessness
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Psychiatric disorders
Stress
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Leukocyturia
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Perinephric collection
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Reproductive system and breast disorders
Penile haematoma
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Vascular disorders
Haematoma
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Vascular disorders
Hypertension
|
66.7%
4/6 • 12 Months
|
60.0%
3/5 • 12 Months
|
50.0%
4/8 • 12 Months
|
25.0%
2/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
50.0%
4/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
40.0%
2/5 • 12 Months
|
|
Gastrointestinal disorders
Faeces hard
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
37.5%
3/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
chills
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
General disorders
Fatigue
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
General physical health deterioration
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
Malaise
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
Oedema peripheral
|
50.0%
3/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
Pain
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
General disorders
Puncture site haematoma
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
General disorders
Pyrexia
|
33.3%
2/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Immune system disorders
Transplant Rejection
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
3/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
50.0%
4/8 • 12 Months
|
25.0%
2/8 • 12 Months
|
40.0%
2/5 • 12 Months
|
|
Blood and lymphatic system disorders
Nephrogenic Anemia
|
33.3%
2/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Drain site complication
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
12.5%
1/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
20.0%
1/5 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
25.0%
2/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
16.7%
1/6 • 12 Months
|
0.00%
0/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • 12 Months
|
20.0%
1/5 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/8 • 12 Months
|
0.00%
0/5 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place