Trial Outcomes & Findings for Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation (NCT NCT01967888)

NCT ID: NCT01967888

Last Updated: 2023-11-02

Results Overview

Insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycemic control, as defined by: * a glycated hemoglobin (HbA1c) level \<6.5%; * fingerstick fasting blood glucose not exceeding 126 mg/dL more than three times in the past week (based on a minimum of one daily measurement; * a 2 hour post-prandial blood glucose not exceeding 180 mg/dL more than four times in the past week (based on a minimum of one daily measurement); * a laboratory fasting glucose in the non-diabetic range (\<126 mg/dL).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 104 participants
• Primary outcome timeframe: day 365±14 after the transplant
• Results posted on: 2023-11-02

Participant Flow

Participant milestones

Measure	Reparixin Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Overall Study STARTED	52	52
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Measure	Reparixin Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Overall Study Lost to Follow-up	6	4
Overall Study Withdrawal by Subject	1	1
Overall Study Did Not Have Transplant	1	0
Overall Study Research visit not done, data recorded	1	0
Overall Study Subject excluded after randomization	1	0
Overall Study Patient didn't proceed to pancreatectomy	0	1
Overall Study Subject Unable To Comply With Final Day	0	1

Baseline Characteristics

Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation

Baseline characteristics by cohort

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	52 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	40.0 years STANDARD_DEVIATION 14.4 • n=5 Participants	39.0 years STANDARD_DEVIATION 10.0 • n=7 Participants	39.5 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	38 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	49 participants n=7 Participants	95 participants n=5 Participants

PRIMARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

Insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycemic control, as defined by:

• a glycated hemoglobin (HbA1c) level <6.5%;
• fingerstick fasting blood glucose not exceeding 126 mg/dL more than three times in the past week (based on a minimum of one daily measurement;
• a 2 hour post-prandial blood glucose not exceeding 180 mg/dL more than four times in the past week (based on a minimum of one daily measurement);
• a laboratory fasting glucose in the non-diabetic range (<126 mg/dL).

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Percentage of Patients Who Were Insulin Independent After Islet Autotransplantation (IAT) at Day 365±14 Days After Transplant.	20.0 Percentage of participants	21.2 Percentage of participants

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

AUC for the serum C-peptide level is calculated during the first 4 hours of an MMTT, normalized by the number of Islet Equivalent (IEQ)/kg

Outcome measures

Measure	Reparixin n=43 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=48 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Area Under the Curve (AUC) for the Serum C-peptide Level at Day 75±14 After the Transplant	0.5314796 (ng/mL)/(IEQ/kg)*1000 Standard Deviation 0.3520819	0.6827533 (ng/mL)/(IEQ/kg)*1000 Standard Deviation 0.4769178

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT

AUC for the serum C-peptide level is calculated during the first 4 hours of a mixed meal tolerance test (MMTT), normalized by the number of Islet Equivalent (IEQ)/kg

Outcome measures

Measure	Reparixin n=33 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=41 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Area Under the Curve (AUC) for the Serum C-peptide Level at Day 365±14 After the Transplant	0.5563432 (ng/mL)/(IEQ/kg)*1000 Standard Deviation 0.3133415	0.6865954 (ng/mL)/(IEQ/kg)*1000 Standard Deviation 0.4464460

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

Daily insulin is reported as IU/kg and intake averaged over the previous week.

Outcome measures

Measure	Reparixin n=44 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=49 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Average Daily Insulin Requirements at Day 75±14 After the Transplant	0.2125 IU/kg/day Standard Deviation 0.1643	0.2190 IU/kg/day Standard Deviation 0.1589

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

Daily insulin is reported as IU/kg and intake averaged over the previous week.

Outcome measures

Measure	Reparixin n=39 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=43 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Average Daily Insulin Requirements at Day 365±14 After the Transplant	0.1723 IU/kg/day Standard Deviation 0.1893	0.1823 IU/kg/day Standard Deviation 0.1994

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT

Data of this outcome are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=42; 46
• 30 min; N=40; 46
• 60 min; N=40; 46
• 90 min; N=40; 46
• 120 min; N=41; 46
• 180 min; N=40; 46
• 240 min; N=39; 44

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time Course From Basal to 240 Min of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant	157.0894 mg/dL Standard Error 11.98160	166.5535 mg/dL Standard Error 11.45706

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints"

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=34; 42 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=34; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 41
• 240 min; N=33; 41

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time Course From Basal to 240 Min of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant	157.9988 mg/dL Standard Error 12.00455	180.9442 mg/dL Standard Error 12.08647

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=44; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=43; 47
• 30 min; N=41; 47
• 60 min; N=42; 47
• 90 min; N=42; 47
• 120 min; N=42; 47
• 180 min; N=41; 47
• 240 min; N=40; 44

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time Course From Basal to 240 Min of C-peptide Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant	1.8976 ng/mL Standard Error 0.20787	2.1051 ng/mL Standard Error 0.20104

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=33; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=33; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 40
• 240 min; N=33; 41

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time Course From Basal to 240 Min of C-peptide Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant	1.6052 ng/mL Standard Error 0.24507	1.8822 ng/mL Standard Error 0.24763

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=43; 47
• 30 min; N=41; 47
• 60 min; N=41; 47
• 90 min; N=41; 47
• 120 min; N=42; 47
• 180 min; N=41; 47
• 240 min; N=40; 44

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time Course From Basal to 240 Min of Insulin Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant	23.67209 UIU/mL Standard Error 3.497499	23.57493 UIU/mL Standard Error 3.378854

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=34; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal)
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=34; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 41
• 240 min; N=33; 40

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time Course From Basal to 240 Min of Insulin Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant	22.85522 UIU/mL Standard Error 3.718512	21.77905 UIU/mL Standard Error 3.757573

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for:

• fasting plasma glucose,
• HbA1c,
• stimulated C-peptide
• insulin requirement subscales. The higher the total score, the better the outcome.
• Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
• HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
• Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
• Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)

Outcome measures

Measure	Reparixin n=42 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=47 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
β-cell Function at Day 75±14 After the Transplant	5.7 score on a scale Standard Deviation 1.6	5.2 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for glucose, HbA1c, stimulated C-peptide and insulin requirement subscales.

The higher the total score the better the outcome.

• Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
• HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
• Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
• Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)

Outcome measures

Measure	Reparixin n=32 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=41 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
β-cell Function at Day 365±14 After the Transplant	5.9 score on a scale Standard Deviation 2.0	5.4 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT

Percentage of patients with a glycated haemoglobin (HbA1c) <6.5% at day 365±14 after the transplant.

Outcome measures

Measure	Reparixin n=42 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=45 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Proportion of Patients With an HbA1c <6.5% at Day 365±14 After the Transplant	64.3 percentage of participants Interval 49.79 to 78.78	62.2 percentage of participants Interval 48.06 to 76.39

SECONDARY outcome

Timeframe: from day 75±14 to day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.

Outcome measures

Measure	Reparixin n=41 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=44 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Cumulative Number of Severe Hypoglycemic Events From Day 75±14 to Day 365±14 After the Transplant	0.1 number of events Standard Deviation 0.94	0.0 number of events Standard Deviation 0.21

SECONDARY outcome

Timeframe: from day 75±14 to day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

Percentage of patients with an HbA1c <6.5% at day 365±14 after the transplant AND free of severe hypoglycemic events from day 75±14 to day 365±14 after the transplant inclusive.A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.

Outcome measures

Measure	Reparixin n=39 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=44 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Proportion of Patients With an HbA1c <6.5% at Day 365±14 After the Transplant AND Free of Severe Hypoglycemic Events From Day 75±14 to Day 365±14 After the Transplant Inclusive	64.1 percentage of participants Interval 49.05 to 79.16	59.1 percentage of participants Interval 44.56 to 73.62

SECONDARY outcome

Timeframe: up to day 365±14 after the transplant

Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received. Eligible patients are included in this population whether or not they receive IAT.

The percentages of patients with any treatment emergent adverse events (TEAE, serious and non serious) and with serious TEAE by severity are presented.

Patients with multiple events within a particular system organ class or preferred term were counted only under the category of their most severe event within that system organ class or preferred term.

A serious AE was defined as any untoward medical occurrence that at any dose:

• Resulted in death
• Was life-threatening (ie, the patient was at risk of death at the time of the event)
• Required inpatient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability/incapacity
• Was a congenital anomaly/birth defect
• Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study TEAE- Mild events	90.0 percentage of patients	92.3 percentage of patients
Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study TEAE - Moderate events	90.0 percentage of patients	80.8 percentage of patients
Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study TEAE - Severe events	64.0 percentage of patients	53.8 percentage of patients
Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study serious TEAE- Mild events	18.0 percentage of patients	23.1 percentage of patients
Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study serious TEAE- Moderate events	22.0 percentage of patients	13.5 percentage of patients
Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study serious TEAE- Severe events	42.0 percentage of patients	32.7 percentage of patients

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Malnutrition risk levels are defined as:

• Poor prognosis = pre-albumin level <5.0 mg/dL
• Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
• Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
• Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL

Outcome measures

Measure	Reparixin n=42 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=46 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 75±14 After the Transplant poor prognosis	0 percentage of patients Interval 0.0 to 8.41	0 percentage of patients Interval 0.0 to 7.71
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 75±14 After the Transplant significant risk	9.5 percentage of patients Interval 2.66 to 22.62	4.3 percentage of patients Interval 0.53 to 14.84
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 75±14 After the Transplant increased risk	45.2 percentage of patients Interval 29.85 to 61.33	28.3 percentage of patients Interval 15.99 to 43.46
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 75±14 After the Transplant normal	45.2 percentage of patients Interval 29.85 to 61.33	67.4 percentage of patients Interval 51.98 to 80.47

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Malnutrition risk levels are defined as:

• Poor prognosis = pre-albumin level <5.0 mg/dL
• Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
• Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
• Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL

Outcome measures

Measure	Reparixin n=40 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=44 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 365±14 After the Transplant Poor prognosis	5.0 percentage of participants Interval 0.61 to 16.92	0 percentage of participants Interval 0.0 to 8.04
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 365±14 After the Transplant Significant risk	2.5 percentage of participants Interval 0.06 to 13.16	6.8 percentage of participants Interval 1.43 to 18.66
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 365±14 After the Transplant Increased risk	27.5 percentage of participants Interval 14.6 to 43.89	9.1 percentage of participants Interval 2.53 to 21.67
Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 365±14 After the Transplant Normal	65.0 percentage of participants Interval 48.32 to 79.37	84.1 percentage of participants Interval 69.93 to 93.36

SECONDARY outcome

Timeframe: day 75±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

• No steatorrhea;
• Steatorrhea few times per week;
• Steatorrhea daily;
• Stool incontinence.

Outcome measures

Measure	Reparixin n=44 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=48 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Proportion of Patients by Steatorrhea Severity at Day 75±14 After the Transplant no steatorrhea	54.5 percentage of participants Interval 38.85 to 69.61	64.6 percentage of participants Interval 49.46 to 77.84
Proportion of Patients by Steatorrhea Severity at Day 75±14 After the Transplant steatorrhea few times per week	29.5 percentage of participants Interval 16.76 to 45.2	25.0 percentage of participants Interval 13.64 to 39.6
Proportion of Patients by Steatorrhea Severity at Day 75±14 After the Transplant steatorrhea daily	11.4 percentage of participants Interval 3.79 to 24.56	6.3 percentage of participants Interval 1.31 to 17.2
Proportion of Patients by Steatorrhea Severity at Day 75±14 After the Transplant stool incontinence	4.5 percentage of participants Interval 0.56 to 15.47	4.2 percentage of participants Interval 0.51 to 14.25

SECONDARY outcome

Timeframe: day 365±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

• No steatorrhea;
• Steatorrhea few times per week;
• Steatorrhea daily;
• Stool incontinence.

Outcome measures

Measure	Reparixin n=42 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=46 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Proportion of Patients by Steatorrhea Severity at Day 365±14 After the Transplant no steatorrhea	52.4 percentage of participants Interval 36.42 to 68.0	58.7 percentage of participants Interval 43.23 to 73.0
Proportion of Patients by Steatorrhea Severity at Day 365±14 After the Transplant steatorrhea few times per week	26.2 percentage of participants Interval 13.86 to 42.04	19.6 percentage of participants Interval 9.36 to 33.91
Proportion of Patients by Steatorrhea Severity at Day 365±14 After the Transplant steatorrhea daily	21.4 percentage of participants Interval 10.3 to 36.81	21.7 percentage of participants Interval 10.95 to 36.36
Proportion of Patients by Steatorrhea Severity at Day 365±14 After the Transplant stool incontinence	0 percentage of participants Interval 0.0 to 8.41	0 percentage of participants Interval 0.0 to 7.71

SECONDARY outcome

Timeframe: from day 75±14 to day 365±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

The following definition applies:

• Asymptomatic hypoglycemia = An event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <70mg/dL.

Outcome measures

Measure	Reparixin n=41 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=45 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Cumulative Number of Episodes of Documented Asymptomatic Hypoglycemia From Day 75±14 to Day 365±14 After the Transplant	1.5 number of episodes Standard Deviation 4.3	4.4 number of episodes Standard Deviation 25.6

SECONDARY outcome

Timeframe: from day 75±14 to day 365±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

The following definition applies:

• Documented symptomatic hypoglycemia = An event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <70mg/dL.

Outcome measures

Measure	Reparixin n=41 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=45 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Cumulative Number of Episodes of Documented Symptomatic Hypoglycemia From Day 75±14 to Day 365±14 After the Transplant	4.6 number of episodes Standard Deviation 13.9	4.8 number of episodes Standard Deviation 17.8

SECONDARY outcome

Timeframe: from day 75±14 to day 365±14 after the transplant

Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

A diabetic ketoacidosis event is defined as the presence of:

• hyperglycemia (blood glucose >200 mg/dL);
• pH <7.3 or HCO3 <15;
• ketones positive in the serum or urine.

Outcome measures

Measure	Reparixin n=41 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=46 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Cumulative Number of Diabetic Ketoacidosis-related Events	0.0 number of events Standard Deviation 0.0	0.0 number of events Standard Deviation 0.0

SECONDARY outcome

Timeframe: Day 75±14 after the transplant

Population: ITT population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.

Outcome measures

Measure	Reparixin n=44 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=48 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Peak C-peptide at Day 75 After the Transplant	2.640 ng/mL Standard Deviation 1.529	2.900 ng/mL Standard Deviation 1.753

SECONDARY outcome

Timeframe: Day 365±14 after the transplant

Population: ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.

Outcome measures

Measure	Reparixin n=34 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=41 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Peak C-peptide at Day 365 After the Transplant	2.630 ng/mL Standard Deviation 1.467	3.170 ng/mL Standard Deviation 1.843

SECONDARY outcome

Timeframe: day 75±14 and day 365±14 after the transplant

Population: ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

The time-to-peak value in minutes was computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test Case Report Form.

Outcome measures

Measure	Reparixin n=43 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=44 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time-to-peak C-peptide at Day 75 After the Transplant	104.2 minutes Standard Deviation 93.6	108.7 minutes Standard Deviation 59.4

SECONDARY outcome

Timeframe: Day 365±14 after the transplant

Population: ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

The time to peak value in minutes will be computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test CRF.

Outcome measures

Measure	Reparixin n=31 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=40 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Time-to-peak C-peptide at Day 365 After the Transplant	97.8 minutes Standard Deviation 90.9	102.0 minutes Standard Deviation 56.2

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 7, 75 ±14 after the transplant

Population: Safety Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• baseline; N=50; 52
• Day 2 post-transplant; N=49; 51
• Day 3 post-transplant; N=47; 50
• Day 7 post-transplant; N=47; 50
• Day 75 post-transplant; N=44; 47

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Change From Baseline in Post-transplant Alanine Aminotransferase (ALT)	60.4105 U/L Standard Error 40.9699	29.0615 U/L Standard Error 40.2724

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 7, 75±14 after the transplant

Population: Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• baseline; N=50; 52
• Day 2 post-transplant; N=49; 51
• Day 3 post-transplant; N=47; 50
• Day 7 post-transplant; N=47; 50
• Day 75 post-transplant; N=44; 47

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Change From Baseline in Post-transplant Aspartate Aminotransferase (AST)	46.8755 U/L Standard Error 27.8248	23.3301 U/L Standard Error 26.6545

SECONDARY outcome

Timeframe: Throughout the study From Day -1 to hospital discharge

Population: Safety Population:Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called "Adverse reactions" (ADR).

An adverse reaction is defined as any untoward medical occurrence in a patient or clinical investigation patient, which has a causal relationship with the administered medicinal product.

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Number of Treatment Emergent Adverse Events Related to Investigational Product possibly related	20 Number of events	28 Number of events
Number of Treatment Emergent Adverse Events Related to Investigational Product probably related	0 Number of events	0 Number of events
Number of Treatment Emergent Adverse Events Related to Investigational Product highly probably related	0 Number of events	0 Number of events

SECONDARY outcome

Timeframe: Throughout the study From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events

Population: Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population were based on treatment received. Patients randomized but not treated were analyzed in the total summary statistics only.

Serious Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called serious "Adverse reactions".

A serious adverse reaction is defined as any untoward medical occurrence with a causal relationship with the administered medicinal product, that at any dose:

• Resulted in death
• Was life-threatening (ie, the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe.)
• Required patient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability/incapacity
• Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above

Outcome measures

Measure	Reparixin n=50 Participants Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 Participants Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Number of Serious Treatment Emergent Adverse Events Related to Investigational Product possibly related	4 Number of events	1 Number of events
Number of Serious Treatment Emergent Adverse Events Related to Investigational Product probably related	0 Number of events	0 Number of events
Number of Serious Treatment Emergent Adverse Events Related to Investigational Product highly probably related	0 Number of events	0 Number of events

Adverse Events

Reparixin

Serious events: 29 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 30 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reparixin n=50 participants at risk Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 participants at risk Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Injury, poisoning and procedural complications Wound complication	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Dehydration	4.0% 2/50 • Number of events 6 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Malnutrition	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hyperglycaemia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypercalaemia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Pyrexia	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Hernia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Malaise	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Oedema peripheral	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Peripheral swelling	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Vascular stent occlusion	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders respiratory failure	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Depressed levele of consciousness	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Migrane	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Lethargy	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Syncope	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Transaminases increased	4.0% 2/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Abdominal pain	26.0% 13/50 • Number of events 22 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	13.5% 7/52 • Number of events 19 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Vomiting	8.0% 4/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 7 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Nausea	6.0% 3/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 10 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders small intestinal obstruction	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 8 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders abdominal hernia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Colitis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Intra-abdominal fluid collection	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Ascites	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Constipation	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Enteritis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Faecaloma	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Gastrointestinal Haemorrage	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Gastrintestinal necrosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders impaired gastric empting	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders intestinal ischeamia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders omental infarction	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Pneumonia	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Urinary tract infections	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Clostridium difficile infection	4.0% 2/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Clostridium difficile colitis	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Postoperative wound infection	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Sepsis	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Gastrenteritis viral	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Bacterial infection	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Biliary tract infection	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Cellulitis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Gastroenteritis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations gastrointestinal infection	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Influenza	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Joint abscess	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations postoperative abscess	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Urosepsis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Viral infection	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Wound infection	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Accidental overdose	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Incisional hernia	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Arterial injury	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Gastroparesis postoperative	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Post operative hernia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Seroma	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Vascular graft stenosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Hepatic enzyme increased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Leucocytosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Mental status changes	2.0% 1/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Confusion of state	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Hepatobiliary disorders Hepatic function abnormal	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Hepatobiliary disorders Portal vein thrombosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Vascular disorders Hypotension	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Eye disorders Eye pain	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Eye disorders Visual impairment	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Cardiac disorders Sinus tachycardia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.

Other adverse events

Measure	Reparixin n=50 participants at risk Solution for intravenous (IV) infusion with active compound Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour	Placebo n=52 participants at risk Physiologic solution Placebo: Physiologic solution administered at 0.25 mL/kg/hour
Injury, poisoning and procedural complications Procedural pain	74.0% 37/50 • Number of events 37 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	82.7% 43/52 • Number of events 43 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Incision site pain	10.0% 5/50 • Number of events 7 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Procedural nausea	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Seroma	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Procedural vomiting	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypokalaemia	44.0% 22/50 • Number of events 23 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	36.5% 19/52 • Number of events 22 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	22.0% 11/50 • Number of events 11 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	26.9% 14/52 • Number of events 14 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypoglycaemia	20.0% 10/50 • Number of events 12 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	21.2% 11/52 • Number of events 12 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypophosphataemia	18.0% 9/50 • Number of events 9 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	23.1% 12/52 • Number of events 12 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypoalbuminaemia	14.0% 7/50 • Number of events 7 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	11.5% 6/52 • Number of events 6 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypernatraemia	12.0% 6/50 • Number of events 6 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypocalcaemia	8.0% 4/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypoinsulinaemia	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Malnutrition	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Fluid retention	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypermagnesaemia	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypervolaemia	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypovolaemia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Vitamin C deficiency	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Calcium deficiency	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Hypercalaemia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Vitamin A deficiency	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Metabolism and nutrition disorders Fluid overload	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Nausea	38.0% 19/50 • Number of events 26 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	40.4% 21/52 • Number of events 21 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Abdominal pain	16.0% 8/50 • Number of events 10 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Constipation	22.0% 11/50 • Number of events 11 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	30.8% 16/52 • Number of events 16 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Vomiting	16.0% 8/50 • Number of events 8 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	13.5% 7/52 • Number of events 7 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Diarrhoea	8.0% 4/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Abdominal distension	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Abdominal pain upper	4.0% 2/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Ascites	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Dyspepsia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Flatulence	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Ileus	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Intra-abdominal haemorrhage	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Bile acid malabsorption	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Gastrointestinal pain	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Jejunal ulcer	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders mesenteric artery trhombosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Peptic ulcer	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Gastrointestinal disorders Stomatitis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Anaemia	50.0% 25/50 • Number of events 25 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	42.3% 22/52 • Number of events 22 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Leukocytosis	8.0% 4/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Thrombocytosis	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Iron deficiency anaemia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Coagulopathy	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Haemorragic anaemia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Blood and lymphatic system disorders Thrombocytopenia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Urinary tract infection	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	9.6% 5/52 • Number of events 5 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Penumonia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Clostridium difficile infection	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Clostridium difficile colitis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Infection	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Abdominal infection	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Cellulitis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Candida infection	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Escherichia urinary tract infection	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Fungal infection	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Gastroenteritis clostridial	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Genital herpes	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Respiratory moniliasis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Urinary tract infection fungal	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Vaginal infection	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Infections and infestations Wound infection fungal	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Transaminases increased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Haematocrit decreased	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Haemoglobin decreased	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Oxygen saturation decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Urin output decreased	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Alanine aminotransferase increased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Aspartate aminotransferase increased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Bacterial test positive	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood bilirubin increased	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood potassium decreased	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Platelet count decreased	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Platelet count increased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations White blood cell count increased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Mean arterial pressure decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Protein total decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood creatinin decreased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Activated partial thromboplastin time prolonged	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood albumin decreased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood alkalyne phosphatase increased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood glucose decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood magnesium decreased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood phosphorus decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Blood zinc decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations C-reactive protein increased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Catheter culture positive	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Electrocardiogram QT prolonged	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Fibrin degradation products increased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations International normalized ratio increased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Portal vein pressure increased	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Investigations Weight decreased	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Pyrexia	20.0% 10/50 • Number of events 13 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	19.2% 10/52 • Number of events 11 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Oedema peripheral	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Pain	4.0% 2/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Non-cardiac chest pain	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Asthenia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Breackthrough pain	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Chills	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Generalized oedema	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
General disorders Secretion discharge	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Apnoea	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Vascular disorders Hypotension	20.0% 10/50 • Number of events 10 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	23.1% 12/52 • Number of events 13 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Vascular disorders Hypertension	14.0% 7/50 • Number of events 9 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	7.7% 4/52 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Anxiety	8.0% 4/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	21.2% 11/52 • Number of events 11 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Insomnia	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Confusional state	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Delirium	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Depression	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Hallucination	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Mental disorder	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Psychiatric disorders Suicidal ideation	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Skin and subcutaneous tissue disorders Pruritus	14.0% 7/50 • Number of events 7 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	11.5% 6/52 • Number of events 6 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Skin and subcutaneous tissue disorders Rush	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Cardiac disorders Thachycardia	8.0% 4/50 • Number of events 4 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	17.3% 9/52 • Number of events 9 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Cardiac disorders Sinus tachycardia	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Cardiac disorders Angina pectoris	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	13.5% 7/52 • Number of events 8 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Intervertebral disk degeneration	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Muscular wickness	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders ìHeadache	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	5.8% 3/52 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Balance disorder	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Dizziness	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Hypoaesthesia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Neuropathy peripheral	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Paraesthesia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Somnolence	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Stupor	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Nervous system disorders Unresponsive to stimuli	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Dyisuria	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Urinary retention	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	3.8% 2/52 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Bladder pain	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Bladder spasm	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Renal and urinary disorders Haematuria	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Hepatobiliary disorders Portal vein thrombosis	6.0% 3/50 • Number of events 3 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Hepatobiliary disorders Hepatitis	2.0% 1/50 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/50 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	1.9% 1/52 • Number of events 1 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Endocrine disorders Hypothyroidism	4.0% 2/50 • Number of events 2 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.	0.00% 0/52 • From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.

Additional Information

Mauro P. Ferrari, Pharm D

Dompé

Phone: +3902583831

Email: info@dompe.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place