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 Blood was withdrawn at the midpoint of each urine collection.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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	74 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	54.4 years STANDARD_DEVIATION 7.4 • n=5 Participants	55.9 years STANDARD_DEVIATION 6.3 • n=7 Participants	51.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.8 years STANDARD_DEVIATION 8.8 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	50 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Region of Enrollment France	10 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	29 participants n=4 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment Spain	7 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	16 participants n=4 Participants
Region of Enrollment Italy	6 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: 1-3 and 10-12 hours post allograft reperfusion

Population: 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	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.	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.
Creatinine Clearance (CrCl) in the Immediate Post-transplant Period 1-3 hours post-transplant	5.11 mL/min Standard Deviation 8.56	7.44 mL/min Standard Deviation 12.81	6.30 mL/min Standard Deviation 6.26
Creatinine Clearance (CrCl) in the Immediate Post-transplant Period 10-12 hours post-transplant	9.66 mL/min Standard Deviation 10.52	14.45 mL/min Standard Deviation 17.39	10.75 mL/min Standard Deviation 10.93

SECONDARY outcome

Timeframe: daily up to day 7 post-transplant or hospital discharge

Population: 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	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.	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.
Renal Function Tests - Serum Creatinine Day 1	0.686 mmol/L Standard Deviation 0.178	0.643 mmol/L Standard Deviation 0.219	0.651 mmol/L Standard Deviation 0.202
Renal Function Tests - Serum Creatinine Day 2	0.683 mmol/L Standard Deviation 0.244	0.576 mmol/L Standard Deviation 0.254	0.658 mmol/L Standard Deviation 0.278
Renal Function Tests - Serum Creatinine 0.Day 3	0.632 mmol/L Standard Deviation 0.311	0.500 mmol/L Standard Deviation 0.270	0.613 mmol/L Standard Deviation 0.317
Renal Function Tests - Serum Creatinine Day 4	0.589 mmol/L Standard Deviation 0.330	0.427 mmol/L Standard Deviation 0.260	0.601 mmol/L Standard Deviation 0.360
Renal Function Tests - Serum Creatinine Day 5	0.509 mmol/L Standard Deviation 0.281	0.383 mmol/L Standard Deviation 0.253	0.567 mmol/L Standard Deviation 0.367
Renal Function Tests - Serum Creatinine Day 6	0.510 mmol/L Standard Deviation 0.334	0.333 mmol/L Standard Deviation 0.206	0.570 mmol/L Standard Deviation 0.407
Renal Function Tests - Serum Creatinine Day 7	0.474 mmol/L Standard Deviation 0.351	0.318 mmol/L Standard Deviation 0.212	0.542 mmol/L Standard Deviation 0.411

SECONDARY outcome

Timeframe: from Day 1 up to 7 days post-transplant or up to hospital discharge

Population: 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	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.	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.
Renal Function Tests - Calculated Glomerular Filtration Rate Day 6	20.46 mL/min Standard Deviation 24.24	26.64 mL/min Standard Deviation 19.81	20.75 mL/min Standard Deviation 24.01
Renal Function Tests - Calculated Glomerular Filtration Rate Day 7	22.42 mL/min Standard Deviation 22.35	28.06 mL/min Standard Deviation 20.10	22.70 mL/min Standard Deviation 24.45
Renal Function Tests - Calculated Glomerular Filtration Rate Day 1	6.04 mL/min Standard Deviation 2.99	8.03 mL/min Standard Deviation 6.46	7.03 mL/min Standard Deviation 3.48
Renal Function Tests - Calculated Glomerular Filtration Rate Day 2	6.95 mL/min Standard Deviation 5.00	10.68 mL/min Standard Deviation 8.61	8.74 mL/min Standard Deviation 8.06
Renal Function Tests - Calculated Glomerular Filtration Rate Day 3	10.99 mL/min Standard Deviation 12.26	14.86 mL/min Standard Deviation 11.67	13.15 mL/min Standard Deviation 15.22
Renal Function Tests - Calculated Glomerular Filtration Rate Day 4	13.90 mL/min Standard Deviation 15.15	19.64 mL/min Standard Deviation 15.28	15.79 mL/min Standard Deviation 18.57
Renal Function Tests - Calculated Glomerular Filtration Rate Day 5	17.97 mL/min Standard Deviation 22.53	23.91 mL/min Standard Deviation 19.02	18.61 mL/min Standard Deviation 22.03

SECONDARY outcome

Timeframe: from Day 1 up to 7 days post-transplant or up to hospital discharge

Population: 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	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.	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.
Renal Function Tests - Urine Output Day 1	1615.9 mL Standard Deviation 2082.7	1749.9 mL Standard Deviation 2109.9	1925.3 mL Standard Deviation 2214.1
Renal Function Tests - Urine Output Day 2	2242.7 mL Standard Deviation 2236.8	2620.2 mL Standard Deviation 2444.1	2844.5 mL Standard Deviation 2861.2
Renal Function Tests - Urine Output Day 3	2321.1 mL Standard Deviation 2087.8	2979.6 mL Standard Deviation 2000.1	2904.0 mL Standard Deviation 2468.3
Renal Function Tests - Urine Output Day 4	2409.8 mL Standard Deviation 2043.2	2583.3 mL Standard Deviation 1698.6	2939.4 mL Standard Deviation 2585.0
Renal Function Tests - Urine Output Day 5	1958.2 mL Standard Deviation 1609.2	2474.8 mL Standard Deviation 1575.4	2035.4 mL Standard Deviation 1816.7
Renal Function Tests - Urine Output Day 6	1795.8 mL Standard Deviation 1206.2	2239.3 mL Standard Deviation 1228.1	1994.8 mL Standard Deviation 1688.5
Renal Function Tests - Urine Output Day 7	2072.3 mL Standard Deviation 1240.9	2226.1 mL Standard Deviation 1093.2	1805.1 mL Standard Deviation 1390.9

SECONDARY outcome

Timeframe: up to day 7 post-transplant

Population: 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	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.	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.
Number of Patients Requiring Dialysis Within 7 Days Post-transplant Yes	7 Participants	7 Participants	6 Participants
Number of Patients Requiring Dialysis Within 7 Days Post-transplant No	15 Participants	15 Participants	18 Participants
Number of Patients Requiring Dialysis Within 7 Days Post-transplant Unknown	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: up to Day 7 post-transplant

Population: 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	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.	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.
Number of Days on Dialysis Before Resuming Kidney Function	2.5 days Standard Deviation 0.7	1.0 days Standard Deviation 0.0	2.0 days Standard Deviation 0.0

SECONDARY outcome

Timeframe: day 5 post-transplant

Population: 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	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.	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.
Number of Patients With Immediate, Slow and Delayed Graft Function Immediate graft function	6 Participants	10 Participants	7 Participants
Number of Patients With Immediate, Slow and Delayed Graft Function Slow graft function	8 Participants	5 Participants	11 Participants
Number of Patients With Immediate, Slow and Delayed Graft Function Delayed graft function	8 Participants	8 Participants	6 Participants
Number of Patients With Immediate, Slow and Delayed Graft Function Unknown	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: first 30 days post-transplant

Population: 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	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.	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.
Duration of Hospital Stay	14.6 days Standard Deviation 8.4	16.1 days Standard Deviation 7.6	13.3 days Standard Deviation 7.9

SECONDARY outcome

Timeframe: first 30 days post-transplant

Population: 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	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.	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.
Mortality No	24 Participants	23 Participants	25 Participants
Mortality Yes	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: at Month 1, Month 6 and Month 12

Population: 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	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.	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.
Serum Creatinine at Month 1, Month 6 and Month 12 Month 1	0.252 mmo/L Standard Deviation 0.2250	0.169 mmo/L Standard Deviation 0.0777	0.186 mmo/L Standard Deviation 0.0890
Serum Creatinine at Month 1, Month 6 and Month 12 Month 6	0.145 mmo/L Standard Deviation 0.0658	0.139 mmo/L Standard Deviation 0.0417	0.179 mmo/L Standard Deviation 0.1227
Serum Creatinine at Month 1, Month 6 and Month 12 Month 12	0.150 mmo/L Standard Deviation 0.0879	0.150 mmo/L Standard Deviation 0.0618	0.227 mmo/L Standard Deviation 0.2578

SECONDARY outcome

Timeframe: at Month 1, Month 6 and Month 12

Population: 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	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.	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.
Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12 Month 1	42.86 mL/min Standard Deviation 22.56	44.75 mL/min Standard Deviation 16.20	41.21 mL/min Standard Deviation 14.23
Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12 Month 6	52.43 mL/min Standard Deviation 18.18	51.14 mL/min Standard Deviation 12.54	46.93 mL/min Standard Deviation 16.65
Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12 Month 12	53.48 mL/min Standard Deviation 20.39	51.10 mL/min Standard Deviation 15.07	41.74 mL/min Standard Deviation 19.03

SECONDARY outcome

Timeframe: at Month 6 and between Month 6 and Month 12

Population: 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	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.	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.
Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12 Month 6	2 episodes	6 episodes	2 episodes
Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12 Between Month 6 and Month 12	0 episodes	0 episodes	4 episodes

SECONDARY outcome

Timeframe: at Month 1, Month 6 and Month 12

Population: 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	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.	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.
Patient Survival Rate Month 12 - Lost to follow up	1 Participants	0 Participants	0 Participants
Patient Survival Rate Month 1 - Alive	22 Participants	22 Participants	22 Participants
Patient Survival Rate Month 1 - Dead	0 Participants	0 Participants	1 Participants
Patient Survival Rate Month 1 - Lost to follow up	2 Participants	1 Participants	3 Participants
Patient Survival Rate Month 6 - Alive	20 Participants	22 Participants	21 Participants
Patient Survival Rate Month 6 - Dead	0 Participants	0 Participants	0 Participants
Patient Survival Rate Month 6 - Lost to follow up	2 Participants	0 Participants	1 Participants
Patient Survival Rate Month 12 - Alive	19 Participants	21 Participants	21 Participants
Patient Survival Rate Month 12 - Dead	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: at Month 1, Month 6 and Month 12

Population: 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	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.	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.
Graft Survival Rate Month 6 - Graft failed	0 number of grafts	0 number of grafts	1 number of grafts
Graft Survival Rate Month 12 - Graft functioning	18 number of grafts	20 number of grafts	20 number of grafts
Graft Survival Rate Month 1 - Graft functioning	21 number of grafts	22 number of grafts	22 number of grafts
Graft Survival Rate Month 1 - Graft failed	3 number of grafts	1 number of grafts	3 number of grafts
Graft Survival Rate Month 6 - Graft functioning	19 number of grafts	22 number of grafts	20 number of grafts
Graft Survival Rate Month 12 - Graft failed	1 number of grafts	1 number of grafts	0 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: clinical.trials@dompe.com

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