Trial Outcomes & Findings for Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study) (NCT NCT01596062)
NCT ID: NCT01596062
Last Updated: 2014-07-25
Results Overview
CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Day 84 (Week 12) after transplantation
Results posted on
2014-07-25
Participant Flow
With premature end of recruitment only 16 patients were included. Descriptive analysis was done \& statistical method fitted the small number of patients. One final analysis was performed at M6 post-transplantation \& comprised assessment of criteria planned at M3 and M6. Some analysis pertaining to the secondary objectives were not performed.
Participant milestones
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
7
|
|
Overall Study
COMPLETED
|
2
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
Baseline Characteristics
Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)
Baseline characteristics by cohort
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 84 (Week 12) after transplantationPopulation: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84
|
8.4 Weeks * Percentage of saturated CD25
Standard Deviation 1.61
|
11.1 Weeks * Percentage of saturated CD25
Standard Deviation 1.12
|
9.7 Weeks * Percentage of saturated CD25
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantationPopulation: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
CD25 saturation is the percentage of T cells expressing CD25
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 0 (before injection)
|
0.0 percentage of T cells
Standard Deviation 0.00
|
0.0 percentage of T cells
Standard Deviation 0.00
|
0.0 percentage of T cells
Standard Deviation 0.00
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 0 (2 hours after injection)
|
93.7 percentage of T cells
Standard Deviation 10.97
|
96.7 percentage of T cells
Standard Deviation 8.16
|
94.7 percentage of T cells
Standard Deviation 5.19
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 1
|
95.7 percentage of T cells
Standard Deviation 7.51
|
97.7 percentage of T cells
Standard Deviation 5.24
|
99.0 percentage of T cells
Standard Deviation 2.65
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 4 (before injection); (n= 3, 6, 6)
|
100.0 percentage of T cells
Standard Deviation 0.00
|
96.2 percentage of T cells
Standard Deviation 6.88
|
93.7 percentage of T cells
Standard Deviation 9.89
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 4 (2 hours after injection): (n= 3, 6, 5)
|
96.7 percentage of T cells
Standard Deviation 5.77
|
96.3 percentage of T cells
Standard Deviation 6.83
|
84.8 percentage of T cells
Standard Deviation 19.25
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 6: (n= 3, 6, 6)
|
98.7 percentage of T cells
Standard Deviation 2.31
|
100.0 percentage of T cells
Standard Deviation 0.00
|
94.0 percentage of T cells
Standard Deviation 14.70
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 14: (n= 3, 6, 6)
|
98.3 percentage of T cells
Standard Deviation 2.89
|
96.7 percentage of T cells
Standard Deviation 7.23
|
97.3 percentage of T cells
Standard Deviation 6.53
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 21: (n= 3, 6, 6)
|
100.0 percentage of T cells
Standard Deviation 0.00
|
94.5 percentage of T cells
Standard Deviation 10.80
|
92.5 percentage of T cells
Standard Deviation 11.83
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 28: (n= 3, 6, 6)
|
95.3 percentage of T cells
Standard Deviation 4.16
|
100.0 percentage of T cells
Standard Deviation 0.00
|
92.7 percentage of T cells
Standard Deviation 9.33
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 42: (n= 3, 6, 5)
|
78.3 percentage of T cells
Standard Deviation 9.07
|
100.0 percentage of T cells
Standard Deviation 0.00
|
99.2 percentage of T cells
Standard Deviation 1.79
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 56: (n= 3, 6, 5)
|
65.0 percentage of T cells
Standard Deviation 56.35
|
93.3 percentage of T cells
Standard Deviation 13.20
|
94.2 percentage of T cells
Standard Deviation 12.97
|
|
Saturation Rate of CD25 Antigen Saturation by Basiliximab
Day 84 (Week 12): (n= 3, 6, 5)
|
0.0 percentage of T cells
Standard Deviation 0.00
|
67.5 percentage of T cells
Standard Deviation 48.55
|
14.2 percentage of T cells
Standard Deviation 20.86
|
SECONDARY outcome
Timeframe: Day 84 (Week 12) post-transplantationPopulation: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
Mean AUC was calculated only for patients who received two Simulect injections.
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84
|
7.0 Weeks * Percentage of T cells
Standard Deviation 1.80
|
9.9 Weeks * Percentage of T cells
Standard Deviation 2.22
|
8.4 Weeks * Percentage of T cells
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantationPopulation: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
This is the percentage of T cells binding basiliximab at all timepoints.
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 0 (before injection)
|
0.0 Percentage of T cells
Standard Deviation 0.00
|
0.0 Percentage of T cells
Standard Deviation 0.00
|
4.7 Percentage of T cells
Standard Deviation 12.47
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 0 (2 hours after injection)
|
95.3 Percentage of T cells
Standard Deviation 8.08
|
96.2 Percentage of T cells
Standard Deviation 9.39
|
81.6 Percentage of T cells
Standard Deviation 28.30
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 1 (n= 3, 5, 7)
|
70.0 Percentage of T cells
Standard Deviation 28.58
|
64.8 Percentage of T cells
Standard Deviation 35.15
|
91.4 Percentage of T cells
Standard Deviation 11.65
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 4 (before injection): (n= 3, 6, 6)
|
100.0 Percentage of T cells
Standard Deviation 0.00
|
59.0 Percentage of T cells
Standard Deviation 45.98
|
53.0 Percentage of T cells
Standard Deviation 33.33
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 4 (2 hours after injection): (n= 3, 5, 5)
|
100.0 Percentage of T cells
Standard Deviation 0.00
|
83.4 Percentage of T cells
Standard Deviation 20.14
|
81.2 Percentage of T cells
Standard Deviation 16.02
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 6: (n= 3, 6, 6)
|
91.7 Percentage of T cells
Standard Deviation 14.43
|
99.0 Percentage of T cells
Standard Deviation 2.45
|
98.3 Percentage of T cells
Standard Deviation 4.08
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 14: (n= 3, 6, 6)
|
100.0 Percentage of T cells
Standard Deviation 0.00
|
89.0 Percentage of T cells
Standard Deviation 22.00
|
93.8 Percentage of T cells
Standard Deviation 15.11
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 21: (n= 3, 6, 6)
|
89.0 Percentage of T cells
Standard Deviation 19.05
|
87.7 Percentage of T cells
Standard Deviation 26.93
|
85.8 Percentage of T cells
Standard Deviation 32.31
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 28: (n= 3, 6, 6)
|
76.3 Percentage of T cells
Standard Deviation 17.62
|
91.0 Percentage of T cells
Standard Deviation 14.00
|
82.7 Percentage of T cells
Standard Deviation 26.29
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 42: (n= 3, 6, 5)
|
47.3 Percentage of T cells
Standard Deviation 28.22
|
84.0 Percentage of T cells
Standard Deviation 19.75
|
78.8 Percentage of T cells
Standard Deviation 30.11
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 56: (n= 3, 6, 5)
|
53.0 Percentage of T cells
Standard Deviation 41.80
|
88.8 Percentage of T cells
Standard Deviation 27.35
|
75.2 Percentage of T cells
Standard Deviation 15.29
|
|
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
Day 84 (Week 12): (n= 3, 6, 5)
|
6.7 Percentage of T cells
Standard Deviation 6.11
|
57.7 Percentage of T cells
Standard Deviation 43.83
|
15.8 Percentage of T cells
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: Day 0, Day 6, Day 42, Day 84 (Week 12)Population: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry).
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD3 cells count at Day 42: (n= 3, 6, 5)
|
0.5 10^9 cells/L
Standard Deviation 0.09
|
1.2 10^9 cells/L
Standard Deviation 0.96
|
1.1 10^9 cells/L
Standard Deviation 1.18
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD3 cells count at Day 0 (before injection)
|
0.5 10^9 cells/L
Standard Deviation 0.25
|
0.9 10^9 cells/L
Standard Deviation 0.28
|
0.7 10^9 cells/L
Standard Deviation 0.28
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD3 cells count at Day 6: (n= 3, 6, 6)
|
0.6 10^9 cells/L
Standard Deviation 0.39
|
1.1 10^9 cells/L
Standard Deviation 0.50
|
0.9 10^9 cells/L
Standard Deviation 0.75
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD3 cells count at Day 84 (Week 12): (n= 3, 6, 6)
|
0.8 10^9 cells/L
Standard Deviation 0.58
|
1.2 10^9 cells/L
Standard Deviation 0.72
|
1.1 10^9 cells/L
Standard Deviation 1.22
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD4 cells count at Day 0 (before injection)
|
0.4 10^9 cells/L
Standard Deviation 0.19
|
0.6 10^9 cells/L
Standard Deviation 0.20
|
0.5 10^9 cells/L
Standard Deviation 0.22
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD4 cells count at Day 6: (n= 3, 6, 6)
|
0.5 10^9 cells/L
Standard Deviation 0.30
|
0.7 10^9 cells/L
Standard Deviation 0.28
|
0.6 10^9 cells/L
Standard Deviation 0.59
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD4 cells count at Day 42: (n= 3, 6, 5)
|
0.3 10^9 cells/L
Standard Deviation 0.08
|
0.8 10^9 cells/L
Standard Deviation 0.53
|
0.8 10^9 cells/L
Standard Deviation 0.82
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD4 cells count at Day 84 (Week 12): (n= 3, 6, 6)
|
0.6 10^9 cells/L
Standard Deviation 0.36
|
0.8 10^9 cells/L
Standard Deviation 0.42
|
0.7 10^9 cells/L
Standard Deviation 0.86
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD8 cells count at Day 0 (before injection)
|
0.1 10^9 cells/L
Standard Deviation 0.05
|
0.3 10^9 cells/L
Standard Deviation 0.13
|
0.2 10^9 cells/L
Standard Deviation 0.15
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD8 cells count at Day 6: (n= 3, 6, 6)
|
0.2 10^9 cells/L
Standard Deviation 0.08
|
0.3 10^9 cells/L
Standard Deviation 0.25
|
0.2 10^9 cells/L
Standard Deviation 0.24
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD8 cells count at Day 42: (n= 3, 6, 5)
|
0.1 10^9 cells/L
Standard Deviation 0.05
|
0.3 10^9 cells/L
Standard Deviation 0.44
|
0.4 10^9 cells/L
Standard Deviation 0.37
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD8 cells count at Day 84 (Week 12): (n= 3, 6, 6)
|
0.2 10^9 cells/L
Standard Deviation 0.24
|
0.3 10^9 cells/L
Standard Deviation 0.32
|
0.3 10^9 cells/L
Standard Deviation 0.37
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD19 cells count at Day 0 (before injection)
|
0.1 10^9 cells/L
Standard Deviation 0.08
|
0.1 10^9 cells/L
Standard Deviation 0.10
|
0.1 10^9 cells/L
Standard Deviation 0.05
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD19 cells count at Day 6: (n=3, 6, 6)
|
0.1 10^9 cells/L
Standard Deviation 0.07
|
0.2 10^9 cells/L
Standard Deviation 0.27
|
0.2 10^9 cells/L
Standard Deviation 0.17
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD19 cells count at Day 42: (n= 3, 6, 5)
|
0.1 10^9 cells/L
Standard Deviation 0.09
|
0.2 10^9 cells/L
Standard Deviation 0.21
|
0.2 10^9 cells/L
Standard Deviation 0.18
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD19 cells count at Day 84 (Week 12): (n= 3, 6, 6)
|
0.2 10^9 cells/L
Standard Deviation 0.20
|
0.1 10^9 cells/L
Standard Deviation 0.11
|
0.1 10^9 cells/L
Standard Deviation 0.15
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD56 cells count at Day 0 (before injection)
|
0.1 10^9 cells/L
Standard Deviation 0.20
|
0.2 10^9 cells/L
Standard Deviation 0.14
|
0.2 10^9 cells/L
Standard Deviation 0.31
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD56 cells count at Day 6: (n= 3, 6, 6)
|
0.1 10^9 cells/L
Standard Deviation 0.00
|
0.1 10^9 cells/L
Standard Deviation 0.06
|
0.2 10^9 cells/L
Standard Deviation 0.25
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD56 cells count at Day 42: (n= 3, 6, 5)
|
0.1 10^9 cells/L
Standard Deviation 0.05
|
0.2 10^9 cells/L
Standard Deviation 0.10
|
0.2 10^9 cells/L
Standard Deviation 0.13
|
|
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
CD56 cells count at Day 84 (Week 12): (n= 3, 6, 6)
|
0.1 10^9 cells/L
Standard Deviation 0.05
|
0.1 10^9 cells/L
Standard Deviation 0.03
|
0.1 10^9 cells/L
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Day 84 (Week 12), Week 24 post-transplantationPopulation: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant.
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)
Day 84 (Week 12): No
|
66.7 Percentage of participants
|
83.3 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)
Day 84 (Week 12):Yes
|
33.3 Percentage of participants
|
16.7 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)
Week 24: No
|
66.7 Percentage of participants
|
83.3 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)
Week 24:Yes
|
33.3 Percentage of participants
|
16.7 Percentage of participants
|
57.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 84 (Week 12), Week 24 post-transplantationPopulation: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising \> 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation).
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Antibody mediated AR - No
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Banff type lll (C AR)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Banff type llA
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Antibody mediated AR - Yes
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Cellular AR - No
|
100.0 Percentage of participants
|
83.3 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Cellular AR - Yes
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Banff type lA
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Banff type lB
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Banff type llA
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Day 84 (Week 12): Banff type llB
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Antibody mediated AR - No
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Antibody mediated AR - Yes
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Cellular AR - No
|
100.0 Percentage of participants
|
83.3 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Cellular AR - Yes
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Banff type lA
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Banff type lB
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Banff type llB
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Week 24: Banff type lll
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 84 (Week 12), Week 24Population: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts.
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Percentage of Participants With of Treatment Failures
Day 84 (Week 12): Death - No
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: Graft loss - No
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day84 (Week 12): BPAR and/or borderline lesions-No
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day84 (Week 12):BPAR and/or borderline lesions-Yes
|
33.3 Percentage of participants
|
33.3 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day 84 (Week 12): Graft loss - No
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day 84 (Week 12): Graft loss - Yes
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day 84 (Week 12): Death - Yes
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day 84 (Week 12): Loss to follow-up - No
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Day 84 (Week 12): Loss to follow-up - Yes
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: BPAR or borderline lesions - No
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: Death - No
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: Loss to follow-up - No
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: Loss to follow-up - Yes
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: BPAR or borderline lesions - Yes
|
33.3 Percentage of participants
|
33.3 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: Graft loss - Yes
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With of Treatment Failures
Week 24: Death - Yes
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 8, Week 24Population: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
(MDRDa formula) with imputation by last observation carried forward (LOCF)
Outcome measures
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 Participants
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 Participants
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24
Week 24 (n= 3, 6, 6)
|
31.9 mL/min/1.73m^2
Standard Deviation 27.93
|
55.7 mL/min/1.73m^2
Standard Deviation 15.68
|
54.4 mL/min/1.73m^2
Standard Deviation 10.48
|
|
Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24
Day 8
|
35.0 mL/min/1.73m^2
Standard Deviation 13.20
|
53.8 mL/min/1.73m^2
Standard Deviation 23.79
|
49.9 mL/min/1.73m^2
Standard Deviation 18.45
|
Adverse Events
Simulect 40mg + Neoral + Myfortic + Steroids
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Simulect 80mg + Neoral + Myfortic + Steroids
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Simulect 80mg + Certican + Myfortic + Steroids
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 participants at risk
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 participants at risk
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 participants at risk
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Immune system disorders
Transplant rejection
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Femur fracture
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Graft loss
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Vascular disorders
Lymphocele
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
Other adverse events
| Measure |
Simulect 40mg + Neoral + Myfortic + Steroids
n=3 participants at risk
A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Neoral + Myfortic + Steroids
n=6 participants at risk
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
|
Simulect 80mg + Certican + Myfortic + Steroids
n=7 participants at risk
A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3
|
33.3%
2/6
|
28.6%
2/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
33.3%
2/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Lip pruritus
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Oedema
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Oedema peripheral
|
100.0%
3/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Hepatobiliary disorders
Cholestasis
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
33.3%
1/3
|
50.0%
3/6
|
0.00%
0/7
|
|
Infections and infestations
BK virus infection
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Gingival infection
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Otitis media
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Investigations
Weight increased
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Acidosis
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3
|
33.3%
2/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Vascular disorders
Hypertension
|
66.7%
2/3
|
16.7%
1/6
|
57.1%
4/7
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
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 the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER