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Trial Outcomes & Findings for OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation (NCT NCT02522871)

NCT ID: NCT02522871

Last Updated: 2023-06-29

Results Overview

Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

7 days

Results posted on

2023-06-29

Participant Flow

Participant milestones

Participant milestones
Measure
OCS Liver System
Organ Care System (OCS) Liver
Control
Ischemic cold storage (ICS)
Overall Study
STARTED
153
147
Overall Study
As-Treated and Safety Population
153
146
Overall Study
Modified Intent to Treat Population
152
146
Overall Study
Per Protocol Population
151
142
Overall Study
COMPLETED
142
133
Overall Study
NOT COMPLETED
11
14

Reasons for withdrawal

Reasons for withdrawal
Measure
OCS Liver System
Organ Care System (OCS) Liver
Control
Ischemic cold storage (ICS)
Overall Study
Protocol Violation
1
4
Overall Study
Treated without randomization
1
0
Overall Study
Death
9
9
Overall Study
Died in operating room prior to transplant
0
1

Baseline Characteristics

Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
OCS Liver
n=153 Participants
Organ Care System (OCS) Liver
Control
n=146 Participants
Ischemic cold storage (ICS)
Total
n=299 Participants
Total of all reporting groups
Age, Continuous
57.07 years
STANDARD_DEVIATION 10.332 • n=153 Participants
58.59 years
STANDARD_DEVIATION 10.043 • n=146 Participants
57.81 years
STANDARD_DEVIATION 10.204 • n=299 Participants
Sex: Female, Male
Female
51 Participants
n=153 Participants
46 Participants
n=146 Participants
97 Participants
n=299 Participants
Sex: Female, Male
Male
102 Participants
n=153 Participants
100 Participants
n=146 Participants
202 Participants
n=299 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
n=153 Participants
20 Participants
n=146 Participants
39 Participants
n=299 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
123 Participants
n=153 Participants
119 Participants
n=146 Participants
242 Participants
n=299 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
11 Participants
n=153 Participants
7 Participants
n=146 Participants
18 Participants
n=299 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=153 Participants
1 Participants
n=146 Participants
1 Participants
n=299 Participants
Race (NIH/OMB)
Asian
2 Participants
n=153 Participants
2 Participants
n=146 Participants
4 Participants
n=299 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=153 Participants
0 Participants
n=146 Participants
1 Participants
n=299 Participants
Race (NIH/OMB)
Black or African American
12 Participants
n=153 Participants
8 Participants
n=146 Participants
20 Participants
n=299 Participants
Race (NIH/OMB)
White
129 Participants
n=153 Participants
131 Participants
n=146 Participants
260 Participants
n=299 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=153 Participants
0 Participants
n=146 Participants
0 Participants
n=299 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants
n=153 Participants
4 Participants
n=146 Participants
13 Participants
n=299 Participants
Body Mass Index
29.67 kg/m^2
STANDARD_DEVIATION 5.383 • n=153 Participants
29.51 kg/m^2
STANDARD_DEVIATION 5.513 • n=146 Participants
29.59 kg/m^2
STANDARD_DEVIATION 5.438 • n=299 Participants
Model for End-stage Liver Disease (MELD) Score
28.4 scores on a scale
STANDARD_DEVIATION 6.90 • n=153 Participants
28.0 scores on a scale
STANDARD_DEVIATION 5.71 • n=146 Participants
28.2 scores on a scale
STANDARD_DEVIATION 6.34 • n=299 Participants
Primary Diagnosis
Cholestatic diseases
9 Participants
n=153 Participants
8 Participants
n=146 Participants
17 Participants
n=299 Participants
Primary Diagnosis
Chronic hepatitis
27 Participants
n=153 Participants
36 Participants
n=146 Participants
63 Participants
n=299 Participants
Primary Diagnosis
Alcoholic cirrhosis
54 Participants
n=153 Participants
48 Participants
n=146 Participants
102 Participants
n=299 Participants
Primary Diagnosis
Metabolic diseases
6 Participants
n=153 Participants
6 Participants
n=146 Participants
12 Participants
n=299 Participants
Primary Diagnosis
Primary hepatic tumors
14 Participants
n=153 Participants
15 Participants
n=146 Participants
29 Participants
n=299 Participants
Primary Diagnosis
NASH
24 Participants
n=153 Participants
20 Participants
n=146 Participants
44 Participants
n=299 Participants
Primary Diagnosis
Other
19 Participants
n=153 Participants
13 Participants
n=146 Participants
32 Participants
n=299 Participants
Donor Age
45.84 years
STANDARD_DEVIATION 14.904 • n=152 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
46.96 years
STANDARD_DEVIATION 15.223 • n=146 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
46.39 years
STANDARD_DEVIATION 15.046 • n=298 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
Donor age >= 40 years
102 Participants
n=152 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
93 Participants
n=146 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
195 Participants
n=298 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
Donor total cross-clamp time >= 6 hours
48 Participants
n=152 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
56 Participants
n=146 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
104 Participants
n=298 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
DCD age <=55 years
28 Participants
n=152 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
13 Participants
n=146 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
41 Participants
n=298 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
Steatotic liver >0% and <=40% macrosteatosis
95 Participants
n=152 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
86 Participants
n=146 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.
181 Participants
n=298 Participants • Donor Liver Population As Treated. Donor Liver Population As Treated consists of all donor livers for which the potential recipient was randomized, and preservation was initiated using OCS or control. However, one donor liver was excluded due to non-randomization, therefore bringing the Donor Liver Population As Treated to 152 from 153.

PRIMARY outcome

Timeframe: 7 days

Population: 1 subject in each arm (OCS Liver and Control) has missing data and therefore the overall number of participants analyzed is different than the number reported in the Participant Flow.

Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)

Outcome measures

Outcome measures
Measure
OCS Liver - Per Protocol
n=150 Participants
Organ Care System (OCS) Liver - Per protocol population
Control - Per-protocol
n=141 Participants
Ischemic cold storage (ICS) - Per-protocol population
OCS Liver - mITT
n=151 Participants
Organ Care System (OCS) Liver - mITT population
Control - mITT
n=145 Participants
Ischemic cold storage (ICS) - mITT population
Participants With Early Liver Allograft Dysfunction (EAD)
27 Participants
44 Participants
27 Participants
47 Participants

PRIMARY outcome

Timeframe: 30 days

Population: As Treated Population

Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.

Outcome measures

Outcome measures
Measure
OCS Liver - Per Protocol
n=153 Participants
Organ Care System (OCS) Liver - Per protocol population
Control - Per-protocol
n=146 Participants
Ischemic cold storage (ICS) - Per-protocol population
OCS Liver - mITT
Organ Care System (OCS) Liver - mITT population
Control - mITT
Ischemic cold storage (ICS) - mITT population
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
0.046 Events per patient
Standard Deviation .210
0.075 Events per patient
Standard Deviation 0.265
—
—

SECONDARY outcome

Timeframe: 30 days after transplant

Patient survival at day 30 after transplantation

Outcome measures

Outcome measures
Measure
OCS Liver - Per Protocol
n=151 Participants
Organ Care System (OCS) Liver - Per protocol population
Control - Per-protocol
n=142 Participants
Ischemic cold storage (ICS) - Per-protocol population
OCS Liver - mITT
n=152 Participants
Organ Care System (OCS) Liver - mITT population
Control - mITT
n=146 Participants
Ischemic cold storage (ICS) - mITT population
Patient Survival at Day 30 After Transplant
150 Participants
141 Participants
151 Participants
145 Participants

SECONDARY outcome

Timeframe: at initial hospital discharge post liver transplant, an average of 11 days

Patient survival at initial hospital discharge post liver transplantation

Outcome measures

Outcome measures
Measure
OCS Liver - Per Protocol
n=151 Participants
Organ Care System (OCS) Liver - Per protocol population
Control - Per-protocol
n=142 Participants
Ischemic cold storage (ICS) - Per-protocol population
OCS Liver - mITT
n=152 Participants
Organ Care System (OCS) Liver - mITT population
Control - mITT
n=146 Participants
Ischemic cold storage (ICS) - mITT population
Patient Survival at Initial Hospital Discharge Post Liver Transplant
149 Participants
140 Participants
150 Participants
144 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post transplant

Population: per-protocol population

Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 6 Months Follow-up Visit

Outcome measures

Outcome measures
Measure
OCS Liver - Per Protocol
n=151 Participants
Organ Care System (OCS) Liver - Per protocol population
Control - Per-protocol
n=142 Participants
Ischemic cold storage (ICS) - Per-protocol population
OCS Liver - mITT
Organ Care System (OCS) Liver - mITT population
Control - mITT
Ischemic cold storage (ICS) - mITT population
Evidence of Ischemic Biliary Complications Diagnosed at 6 Months
2 Participants
12 Participants
—
—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post transplant

Population: per-protocol population

Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 12 Months Follow-up Visit

Outcome measures

Outcome measures
Measure
OCS Liver - Per Protocol
n=151 Participants
Organ Care System (OCS) Liver - Per protocol population
Control - Per-protocol
n=142 Participants
Ischemic cold storage (ICS) - Per-protocol population
OCS Liver - mITT
Organ Care System (OCS) Liver - mITT population
Control - mITT
Ischemic cold storage (ICS) - mITT population
Evidence of Ischemic Biliary Complications Diagnosed at 12 Months
4 Participants
14 Participants
—
—

Adverse Events

OCS Liver System

Serious events: 82 serious events
Other events: 0 other events
Deaths: 9 deaths

Control

Serious events: 72 serious events
Other events: 0 other events
Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure
OCS Liver System
n=153 participants at risk
Organ Care System (OCS) Liver
Control
n=146 participants at risk
Ischemic Cold Storage (ICS)
Blood and lymphatic system disorders
Anaemia
2.0%
3/153 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Angina pectoris
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Atrial Fibrillation
2.0%
3/153 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.7%
4/146 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Atrioventricular block second degree
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Cardiac arrest
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Intracardiac thrombus
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Myocardial ischaemia
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Tachycardia
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Abdominal pain
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Abdominal pain upper
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Ascites
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.1%
3/146 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Coeliac artery compression syndrome
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Diarrhoea
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Duodenal perforation
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Haematemesis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Haematochezia
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Blood and lymphatic system disorders
Febrile Neutropenia
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Blood and lymphatic system disorders
Intravascular haemolysis
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Cardiac disorders
Arrhythmia
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Haemorrhoids
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Ileus
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Intestinal haemorrhage
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Nausea
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Pancreatitis
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Peritonitis
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Pneumoperitoneum
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Small intestinal obstruction
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Gastrointestinal disorders
Umbilical hernia
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
General disorders
Catheter site haemorrhage
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
General disorders
Oedema
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
General disorders
Oedema peripheral
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
General disorders
Pyrexia
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.7%
4/146 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Bile duct obstruction
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Bile duct stenosis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Biliary ischaemia
2.6%
4/153 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
9.6%
14/146 • Number of events 14 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Cholangitis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Hepatic artery stenosis
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.7%
4/146 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Hepatic artery thrombosis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Hepatic necrosis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Portal vein occlusion
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Portal vein stenosis
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Hepatobiliary disorders
Portal vein thrombosis
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Immune system disorders
Hypersensitivity
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Immune system disorders
Transplant rejection
3.3%
5/153 • Number of events 5 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
4.8%
7/146 • Number of events 8 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Bacteraemia
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Cellulitis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Fungal peritonitis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Influenza
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Pneumonia
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Sepsis
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Septic shock
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Urinary tract infection
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Infections and infestations
Wound infection
2.0%
3/153 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Anastomotic haemorrhage
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Biliary anastomosis complication
8.5%
13/153 • Number of events 13 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
4.1%
6/146 • Number of events 6 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Drug toxicity
3.3%
5/153 • Number of events 5 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Mental status changes postoperative
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Operative haemorrhage
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Post procedural bile leak
2.6%
4/153 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
7.5%
11/146 • Number of events 11 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Post procedural haemorrhage
3.3%
5/153 • Number of events 5 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
4.8%
7/146 • Number of events 7 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Procedural complication
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Seroma
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Spinal fracture
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Vascular procedure complication
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Injury, poisoning and procedural complications
Wound dehiscence
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Investigations
Liver function test abnormal
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Metabolism and nutrition disorders
Failure to thrive
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Metabolism and nutrition disorders
Fluid overload
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Metabolism and nutrition disorders
Hyperkalaemia
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Metabolism and nutrition disorders
Hyponatraemia
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Metabolism and nutrition disorders
Malnutrition
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Cerebrovascular accident
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Convulsion
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
3.4%
5/146 • Number of events 5 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Demyelinating polyneuropathy
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Encephalopathy
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Headache
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Hemiparesis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Hepatic encephalopathy
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Ischaemic stroke
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Metabolic encephalopathy
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Migraine
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Nervous system disorders
Subarachnoid haemorrhage
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Psychiatric disorders
Delirium
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.7%
4/146 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Psychiatric disorders
Mental status changes
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Renal and urinary disorders
Renal failure
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Renal and urinary disorders
Renal failure acute
7.2%
11/153 • Number of events 11 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
4.8%
7/146 • Number of events 7 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.7%
4/146 • Number of events 4 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.3%
2/153 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Reexpansion pulmonary oedema
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
2.0%
3/153 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
2.1%
3/146 • Number of events 3 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Surgical and medical procedures
Hernia repair
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Surgical and medical procedures
Incisional drainage
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Surgical and medical procedures
Inguinal hernia repair
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Air embolism
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Artery dissection
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Deep vein thrombosis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Haematoma
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Haemorrhage
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
1.4%
2/146 • Number of events 2 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Hypovolaemic shock
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Jugular vein thrombosis
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.00%
0/146 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Reperfusion injury
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Shock
0.00%
0/153 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
Vascular disorders
Vascular shunt
0.65%
1/153 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.
0.68%
1/146 • Number of events 1 • Serious adverse events (SAEs) were collected through 30 days post-transplant or initial hospital discharge. Liver-graft related serious adverse events (LGRSAEs) were collected through 6 months post-transplant, and ischemic biliary complications were collected through 12 months post-transplant. All-cause mortality is reported through 12-months post transplant.
Only death and serious adverse events were assessed. All-Cause Mortality was assessed in 153 participants in the "OCS Liver System" Arm and 147 participants in the "Control" Arm. Serious Adverse Events were monitored in 153 participants in the "OCS Liver System" Arm and 146 participants in the "Control" Arm.

Other adverse events

Adverse event data not reported

Additional Information

Laura Damme

TransMedics

Phone: 978-552-0910

Results disclosure agreements

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