Trial Outcomes & Findings for Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation (NCT NCT00248040)
NCT ID: NCT00248040
Last Updated: 2024-01-10
Results Overview
CrCl was determined by two 60 minute urine collections, during the time intervals 1-3 and 10-12 hours of allograft reperfusion. Blood was withdrawn at the midpoint of each urine collection. CrCl at each timepoint was calculated according to the formula: creatinine clearance (mL/minutes) = urine creatinine (mmol/L) x urine volume (mL) / serum creatinine (mmol/L) x time of collection (minutes) An average was to be calculated from the two 60 minute values in each interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
1-3 and 10-12 hours post allograft reperfusion
Results posted on
2024-01-10
Participant Flow
74 pt. (25 \& 23 in reparixin continuous and intermittent infusion, and 26 in the pooled placebo) received the drug and were included in the safety population; 73 pt. (24, 23, 26) received both the study drug and the transplant and were included in the ITT. 1 started study drug but did not receive a kidney transplant, so was excluded from the ITT.
Six patients (2 in the reparixin continuous infusion group; 3 in the reparixin intermittent infusion group; 1 in the placebo intermittent infusion group) did not receive Investigational Product(s) or kidney transplants and hence they were excluded from both the Safety and ITT populations.
Participant milestones
| Measure |
Reparixin Continuous Infusion
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
Placebo Continuous/Intermittent Infusion
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
26
|
|
Overall Study
COMPLETED
|
22
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
Reasons for withdrawal
| Measure |
Reparixin Continuous Infusion
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
Placebo Continuous/Intermittent Infusion
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
|---|---|---|---|
|
Overall Study
transplantectomy
|
2
|
1
|
3
|
|
Overall Study
transplant cancelled post treat start
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Reparixin Continuous Infusion
n=25 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
55.9 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
51.4 years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
53.8 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
10 participants
n=206 Participants
|
29 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
4 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
8 participants
n=206 Participants
|
21 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1-3 and 10-12 hours post allograft reperfusionPopulation: ITT population. The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
CrCl was determined by two 60 minute urine collections, during the time intervals 1-3 and 10-12 hours of allograft reperfusion. Blood was withdrawn at the midpoint of each urine collection. CrCl at each timepoint was calculated according to the formula: creatinine clearance (mL/minutes) = urine creatinine (mmol/L) x urine volume (mL) / serum creatinine (mmol/L) x time of collection (minutes) An average was to be calculated from the two 60 minute values in each interval.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Creatinine Clearance (CrCl) in the Immediate Post-transplant Period
1-3 hours post-transplant
|
6.30 mL/min
Standard Deviation 6.26
|
5.11 mL/min
Standard Deviation 8.56
|
7.44 mL/min
Standard Deviation 12.81
|
|
Creatinine Clearance (CrCl) in the Immediate Post-transplant Period
10-12 hours post-transplant
|
10.75 mL/min
Standard Deviation 10.93
|
9.66 mL/min
Standard Deviation 10.52
|
14.45 mL/min
Standard Deviation 17.39
|
SECONDARY outcome
Timeframe: daily up to day 7 post-transplant or hospital dischargePopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Serum creatinine (SrCr) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Renal Function Tests - Serum Creatinine
Day 1
|
0.651 mmol/L
Standard Deviation 0.202
|
0.686 mmol/L
Standard Deviation 0.178
|
0.643 mmol/L
Standard Deviation 0.219
|
|
Renal Function Tests - Serum Creatinine
Day 2
|
0.658 mmol/L
Standard Deviation 0.278
|
0.683 mmol/L
Standard Deviation 0.244
|
0.576 mmol/L
Standard Deviation 0.254
|
|
Renal Function Tests - Serum Creatinine
0.Day 3
|
0.613 mmol/L
Standard Deviation 0.317
|
0.632 mmol/L
Standard Deviation 0.311
|
0.500 mmol/L
Standard Deviation 0.270
|
|
Renal Function Tests - Serum Creatinine
Day 4
|
0.601 mmol/L
Standard Deviation 0.360
|
0.589 mmol/L
Standard Deviation 0.330
|
0.427 mmol/L
Standard Deviation 0.260
|
|
Renal Function Tests - Serum Creatinine
Day 5
|
0.567 mmol/L
Standard Deviation 0.367
|
0.509 mmol/L
Standard Deviation 0.281
|
0.383 mmol/L
Standard Deviation 0.253
|
|
Renal Function Tests - Serum Creatinine
Day 6
|
0.570 mmol/L
Standard Deviation 0.407
|
0.510 mmol/L
Standard Deviation 0.334
|
0.333 mmol/L
Standard Deviation 0.206
|
|
Renal Function Tests - Serum Creatinine
Day 7
|
0.542 mmol/L
Standard Deviation 0.411
|
0.474 mmol/L
Standard Deviation 0.351
|
0.318 mmol/L
Standard Deviation 0.212
|
SECONDARY outcome
Timeframe: from Day 1 up to 7 days post-transplant or up to hospital dischargePopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Calculated glomerular filtration rate (GFR) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 1
|
7.03 mL/min
Standard Deviation 3.48
|
6.04 mL/min
Standard Deviation 2.99
|
8.03 mL/min
Standard Deviation 6.46
|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 2
|
8.74 mL/min
Standard Deviation 8.06
|
6.95 mL/min
Standard Deviation 5.00
|
10.68 mL/min
Standard Deviation 8.61
|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 3
|
13.15 mL/min
Standard Deviation 15.22
|
10.99 mL/min
Standard Deviation 12.26
|
14.86 mL/min
Standard Deviation 11.67
|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 4
|
15.79 mL/min
Standard Deviation 18.57
|
13.90 mL/min
Standard Deviation 15.15
|
19.64 mL/min
Standard Deviation 15.28
|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 5
|
18.61 mL/min
Standard Deviation 22.03
|
17.97 mL/min
Standard Deviation 22.53
|
23.91 mL/min
Standard Deviation 19.02
|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 6
|
20.75 mL/min
Standard Deviation 24.01
|
20.46 mL/min
Standard Deviation 24.24
|
26.64 mL/min
Standard Deviation 19.81
|
|
Renal Function Tests - Calculated Glomerular Filtration Rate
Day 7
|
22.70 mL/min
Standard Deviation 24.45
|
22.42 mL/min
Standard Deviation 22.35
|
28.06 mL/min
Standard Deviation 20.10
|
SECONDARY outcome
Timeframe: from Day 1 up to 7 days post-transplant or up to hospital dischargePopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Urine output, measured in the interval from transplant to 8:00 of Day 1, and then daily from Day 2 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Renal Function Tests - Urine Output
Day 1
|
1925.3 mL
Standard Deviation 2214.1
|
1615.9 mL
Standard Deviation 2082.7
|
1749.9 mL
Standard Deviation 2109.9
|
|
Renal Function Tests - Urine Output
Day 2
|
2844.5 mL
Standard Deviation 2861.2
|
2242.7 mL
Standard Deviation 2236.8
|
2620.2 mL
Standard Deviation 2444.1
|
|
Renal Function Tests - Urine Output
Day 3
|
2904.0 mL
Standard Deviation 2468.3
|
2321.1 mL
Standard Deviation 2087.8
|
2979.6 mL
Standard Deviation 2000.1
|
|
Renal Function Tests - Urine Output
Day 4
|
2939.4 mL
Standard Deviation 2585.0
|
2409.8 mL
Standard Deviation 2043.2
|
2583.3 mL
Standard Deviation 1698.6
|
|
Renal Function Tests - Urine Output
Day 5
|
2035.4 mL
Standard Deviation 1816.7
|
1958.2 mL
Standard Deviation 1609.2
|
2474.8 mL
Standard Deviation 1575.4
|
|
Renal Function Tests - Urine Output
Day 6
|
1994.8 mL
Standard Deviation 1688.5
|
1795.8 mL
Standard Deviation 1206.2
|
2239.3 mL
Standard Deviation 1228.1
|
|
Renal Function Tests - Urine Output
Day 7
|
1805.1 mL
Standard Deviation 1390.9
|
2072.3 mL
Standard Deviation 1240.9
|
2226.1 mL
Standard Deviation 1093.2
|
SECONDARY outcome
Timeframe: up to day 7 post-transplantPopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
The number of patients who required dialysis within 7 days post-transplant was evaluated.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Number of Patients Requiring Dialysis Within 7 Days Post-transplant
Yes
|
6 Participants
|
7 Participants
|
7 Participants
|
|
Number of Patients Requiring Dialysis Within 7 Days Post-transplant
No
|
18 Participants
|
15 Participants
|
15 Participants
|
|
Number of Patients Requiring Dialysis Within 7 Days Post-transplant
Unknown
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Day 7 post-transplantPopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
the number of days on dialysis before resuming kidney function was evaluated.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Number of Days on Dialysis Before Resuming Kidney Function
|
2.0 days
Standard Deviation 0.0
|
2.5 days
Standard Deviation 0.7
|
1.0 days
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: day 5 post-transplantPopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
The number of patients who required dialysis within 7 days post-transplant was evaluated. Immediate graft function: SrCr ≤3 mg/dL on post operative day 5) Slow graft function: SrCr \>3 mg/dL dL on post operative day 5, no need of dialysis) Delayed graft function: Dialysis needed in the first week)
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Number of Patients With Immediate, Slow and Delayed Graft Function
Immediate graft function
|
7 Participants
|
6 Participants
|
10 Participants
|
|
Number of Patients With Immediate, Slow and Delayed Graft Function
Slow graft function
|
11 Participants
|
8 Participants
|
5 Participants
|
|
Number of Patients With Immediate, Slow and Delayed Graft Function
Delayed graft function
|
6 Participants
|
8 Participants
|
8 Participants
|
|
Number of Patients With Immediate, Slow and Delayed Graft Function
Unknown
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: first 30 days post-transplantPopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
The mean duration of hospital stay was evaluated.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Duration of Hospital Stay
|
13.3 days
Standard Deviation 7.9
|
14.6 days
Standard Deviation 8.4
|
16.1 days
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: first 30 days post-transplantPopulation: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Mortality in the first 30 days post-transplant was evaluated.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Mortality
No
|
25 Participants
|
24 Participants
|
23 Participants
|
|
Mortality
Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Month 1, Month 6 and Month 12Population: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Serum creatinine (SrCr) was measured at Month 1, Month 6 and Month 12.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Serum Creatinine at Month 1, Month 6 and Month 12
Month 1
|
0.186 mmo/L
Standard Deviation 0.0890
|
0.252 mmo/L
Standard Deviation 0.2250
|
0.169 mmo/L
Standard Deviation 0.0777
|
|
Serum Creatinine at Month 1, Month 6 and Month 12
Month 6
|
0.179 mmo/L
Standard Deviation 0.1227
|
0.145 mmo/L
Standard Deviation 0.0658
|
0.139 mmo/L
Standard Deviation 0.0417
|
|
Serum Creatinine at Month 1, Month 6 and Month 12
Month 12
|
0.227 mmo/L
Standard Deviation 0.2578
|
0.150 mmo/L
Standard Deviation 0.0879
|
0.150 mmo/L
Standard Deviation 0.0618
|
SECONDARY outcome
Timeframe: at Month 1, Month 6 and Month 12Population: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a rapid and cost-effective method for the measurement of renal function.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12
Month 1
|
41.21 mL/min
Standard Deviation 14.23
|
42.86 mL/min
Standard Deviation 22.56
|
44.75 mL/min
Standard Deviation 16.20
|
|
Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12
Month 6
|
46.93 mL/min
Standard Deviation 16.65
|
52.43 mL/min
Standard Deviation 18.18
|
51.14 mL/min
Standard Deviation 12.54
|
|
Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12
Month 12
|
41.74 mL/min
Standard Deviation 19.03
|
53.48 mL/min
Standard Deviation 20.39
|
51.10 mL/min
Standard Deviation 15.07
|
SECONDARY outcome
Timeframe: at Month 6 and between Month 6 and Month 12Population: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Acute rejection defined as an increase in serum creatinine level after exclusion of other causes of graft dysfunction, accompanied by a sudden decline in glomerular filtration rate and renal function and well-established diagnostic features on kidney allograft biopsy which can be either antibody-mediated and/or T cell-mediated and can occur at any time after transplant.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12
Month 6
|
2 episodes
|
2 episodes
|
6 episodes
|
|
Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12
Between Month 6 and Month 12
|
4 episodes
|
0 episodes
|
0 episodes
|
SECONDARY outcome
Timeframe: at Month 1, Month 6 and Month 12Population: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Numbers of patients alive, dead, and lost to follow up are reported.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Patient Survival Rate
Month 6 - Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Survival Rate
Month 1 - Alive
|
22 Participants
|
22 Participants
|
22 Participants
|
|
Patient Survival Rate
Month 1 - Dead
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Patient Survival Rate
Month 1 - Lost to follow up
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Patient Survival Rate
Month 6 - Alive
|
21 Participants
|
20 Participants
|
22 Participants
|
|
Patient Survival Rate
Month 6 - Lost to follow up
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Survival Rate
Month 12 - Alive
|
21 Participants
|
19 Participants
|
21 Participants
|
|
Patient Survival Rate
Month 12 - Dead
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Patient Survival Rate
Month 12 - Lost to follow up
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Month 1, Month 6 and Month 12Population: The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.
Graft failure was defined as the failure of graft function for any reason, ultimately requiring renal replacement therapy and/or retransplantation (United States Renal Data System \[USRDS\] 2017.
Outcome measures
| Measure |
Placebo Continuous/Intermittent Infusion
n=26 Participants
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
Reparixin Continuous Infusion
n=24 Participants
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 Participants
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
|---|---|---|---|
|
Graft Survival Rate
Month 1 - Graft functioning
|
22 number of grafts
|
21 number of grafts
|
22 number of grafts
|
|
Graft Survival Rate
Month 1 - Graft failed
|
3 number of grafts
|
3 number of grafts
|
1 number of grafts
|
|
Graft Survival Rate
Month 6 - Graft functioning
|
20 number of grafts
|
19 number of grafts
|
22 number of grafts
|
|
Graft Survival Rate
Month 6 - Graft failed
|
1 number of grafts
|
0 number of grafts
|
0 number of grafts
|
|
Graft Survival Rate
Month 12 - Graft functioning
|
20 number of grafts
|
18 number of grafts
|
20 number of grafts
|
|
Graft Survival Rate
Month 12 - Graft failed
|
0 number of grafts
|
1 number of grafts
|
1 number of grafts
|
Adverse Events
Reparixin Continuous Infusion
Serious events: 12 serious events
Other events: 24 other events
Deaths: 0 deaths
Reparixin Intermittent Infusion
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Continuous/Intermittent Infusion
Serious events: 9 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Reparixin Continuous Infusion
n=25 participants at risk
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 participants at risk
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
Placebo Continuous/Intermittent Infusion
n=26 participants at risk
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
SEPSIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
OPERATIVE HAEMORRHAGE
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
PERIRENAL HAEMATOMA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
URINARY ANASTOMOTIC LEAK
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL VEIN THROMBOSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URETERIC FISTULA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL ARTERY THROMBOSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
COMPLICATIONS OF TRANSPLANTED KIDNEY
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URETERAL NECROSIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
HYPOTENSION
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
RETROPERITONEAL HAEMORRHAGE
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
Other adverse events
| Measure |
Reparixin Continuous Infusion
n=25 participants at risk
Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.772 mg/kg/h was administered for12 hours.
|
Reparixin Intermittent Infusion
n=23 participants at risk
Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours.
|
Placebo Continuous/Intermittent Infusion
n=26 participants at risk
Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
24.0%
6/25 • Number of events 6 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
43.5%
10/23 • Number of events 10 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
46.2%
12/26 • Number of events 12 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Cardiac disorders
TACHYCARDIA
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Cardiac disorders
PALPITATIONS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
CONSTIPATION
|
32.0%
8/25 • Number of events 8 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
21.7%
5/23 • Number of events 5 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
23.1%
6/26 • Number of events 6 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
5/25 • Number of events 5 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
15.4%
4/26 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
NAUSEA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
13.0%
3/23 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
General disorders
PYREXIA
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
15.4%
4/26 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
General disorders
OEDEMA
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
General disorders
CHEST PAIN
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
General disorders
HAEMORRHAGIC CYST
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
General disorders
PAIN
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Immune system disorders
KIDNEY TRANSPLANT REJECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.0%
4/25 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
21.7%
5/23 • Number of events 5 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
PYELONEPHRITIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
INFECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
SEPSIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
COMPLICATIONS OF TRANSPLANTED KIDNEY
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
FEMORAL NERVE INJURY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
GRAFT COMPLICATION
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
INCISION SITE COMPLICATION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
OPERATIVE HAEMORRHAGE
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
PERINEPHRIC COLLECTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
PERIRENAL HAEMATOMA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE WOUND COMPLICATION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
RENAL HAEMATOMA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
THERAPEUTIC AGENT TOXICITY
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
URINARY ANASTOMOTIC LEAK
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
TRANSAMINASES INCREASED
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
BLOOD AMYLASE INCREASED
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
BLOOD UREA INCREASED
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Investigations
ELECTROCARDIOGRAM T WAVE INVERSION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
24.0%
6/25 • Number of events 6 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
13.0%
3/23 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
15.4%
4/26 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
16.0%
4/25 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
26.1%
6/23 • Number of events 6 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
16.0%
4/25 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
19.2%
5/26 • Number of events 5 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
15.4%
4/26 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
12.0%
3/25 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Psychiatric disorders
INSOMNIA
|
12.0%
3/25 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
20.0%
5/25 • Number of events 5 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
30.4%
7/23 • Number of events 7 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
26.9%
7/26 • Number of events 7 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
BLADDER SPASM
|
16.0%
4/25 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
ANURIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL VEIN THROMBOSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URETERIC FISTULA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
DYSURIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL INFARCT
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
BLADDER PAIN
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
HAEMORRHAGE URINARY TRACT
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
OLIGURIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL TUBULAR DISORDER
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URETERAL NECROSIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URINARY BLADDER ATROPHY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
URINOMA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Reproductive system and breast disorders
SCROTAL OEDEMA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
COMPLICATIONS OF TRANSPLANTED KIDNEY
|
12.0%
3/25 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
15.4%
4/26 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Renal and urinary disorders
RENAL ARTERY THROMBOSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
8.7%
2/23 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
BRADYPNOEA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
HYPOTENSION
|
24.0%
6/25 • Number of events 6 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
21.7%
5/23 • Number of events 5 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
11.5%
3/26 • Number of events 3 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
HYPERTENSION
|
16.0%
4/25 • Number of events 4 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
7.7%
2/26 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
RETROPERITONEAL HAEMORRHAGE
|
8.0%
2/25 • Number of events 2 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
AORTIC ATHEROSCLEROSIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
ARTERIOVENOUS FISTULA THROMBOSIS
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
4.0%
1/25 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
HAEMODYNAMIC INSTABILITY
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
4.3%
1/23 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/26 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
|
Vascular disorders
WOUND HAEMORRHAGE
|
0.00%
0/25 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
0.00%
0/23 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
3.8%
1/26 • Number of events 1 • All AEs were reported up to 10 days or hospital discharge. Thereafter, only untoward events that the Investigator assessed as at least possibly related to the study drug were recorded
|
Additional Information
Clinical Development & Operations
Dompé farmaceutici s.p.a.
Phone: +39 02 583831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER