Trial Outcomes & Findings for Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure (NCT NCT01471028)

Last Updated: 2019-02-15

Results Overview

The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTI-208E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (31 July 2015).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

203 participants

Primary outcome timeframe

Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	ELAD Treatment Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.	Standard of Care (Control) Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
VTI-208 STARTED	96	107
VTI-208 COMPLETED	56	63
VTI-208 NOT COMPLETED	40	44
VTI-208E STARTED	56	63
VTI-208E Database Lock, 31 July 2015	56	63
VTI-208E COMPLETED	48	51
VTI-208E NOT COMPLETED	8	12

Reasons for withdrawal

Reasons for withdrawal
Measure	ELAD Treatment Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.	Standard of Care (Control) Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
VTI-208 Adverse Event	39	41
VTI-208 Withdrawal by Subject	0	2
VTI-208 Lost to Follow-up	1	1
VTI-208E Death	7	10
VTI-208E Withdrawal by Subject	1	0
VTI-208E Lost to Follow-up	0	2

Baseline Characteristics

Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELAD Treatment n=96 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 5 days followed by Standard of Care treatment through Study Day 91.	Standard of Care (Control) n=107 Participants Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.	Total n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=5 Participants	104 Participants n=7 Participants	198 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	46.5 years STANDARD_DEVIATION 9.06 • n=5 Participants	44.8 years STANDARD_DEVIATION 10.66 • n=7 Participants	45.6 years STANDARD_DEVIATION 9.95 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	42 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	65 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants	91 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	83 Participants n=5 Participants	93 Participants n=7 Participants	176 Participants n=5 Participants
Region of Enrollment United Kingdom	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Australia	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Baseline MELD Score	27.6 MELD Score STANDARD_DEVIATION 3.94 • n=5 Participants	27.1 MELD Score STANDARD_DEVIATION 3.79 • n=7 Participants	27.3 MELD Score STANDARD_DEVIATION 3.86 • n=5 Participants

PRIMARY outcome

Timeframe: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)

Outcome measures

Outcome measures
Measure	ELAD Treatment n=96 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.	Standard of Care (Control) n=107 Participants Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Overall Survival	57 Participants	66 Participants

SECONDARY outcome

Timeframe: Up to Study Day 91.

Assess the proportion of survivors at Study Day 91.

Outcome measures

Outcome measures
Measure	ELAD Treatment n=96 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.	Standard of Care (Control) n=107 Participants Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Number of Survivors at Study Day 91.	57 Participants	66 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Study Day 1 up to Study Day 91

An exploratory objective is to evaluate the ability of ELAD® to stabilize liver function, measured using the MELD-based time to progression (TTP), with progression defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.

Outcome measures

Outcome measures
Measure	ELAD Treatment n=96 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.	Standard of Care (Control) n=107 Participants Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Number of Progression-free Survivors at Study Day 91	45 Participants	59 Participants

POST_HOC outcome

Timeframe: Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)

Population: Kaplan-Meier

Creatinine \<1.3 INR \<=2.5 Bilirubin \>=16 Age \<50 MELD \<30

Outcome measures

Outcome measures
Measure	ELAD Treatment n=96 Participants Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care (SOC) treatment for a period of up to 5 days followed by Standard of Care treatment through STudy Day 91.	Standard of Care (Control) n=107 Participants Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Overall Survival for Subjects With Age<50, MELD<30, Bili>=16, INR<=2.5 and Creatinine<1.3	29 Participants	31 Participants

Adverse Events

ELAD Treatment

Serious events: 73 serious events

Other events: 95 other events

Deaths: 38 deaths

Standard of Care (Control)

Serious events: 75 serious events

Other events: 107 other events

Deaths: 42 deaths

Serious adverse events

Other adverse events

Additional Information

Robert Ashley

Vital Therapies, Inc.

Phone: 858-673-6840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	ELAD Treatment n=95 participants at risk Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 5 days followed by Standard of Care treatment through Study Day 91.	Standard of Care (Control) n=108 participants at risk Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Blood and lymphatic system disorders Anaemia	8.4% 8/95 • Number of events 8 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	5.6% 6/108 • Number of events 6 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Coagulopathy	3.2% 3/95 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Disseminated intravascular coagulation	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Leukocytosis	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Thrombocytophenia	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Cardiac arrest	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Cardiac tamponade	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Chest pain	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Supraventricular tachycardia	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Gastrointestinal disorders Abdominal pain	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	3.7% 4/108 • Number of events 5 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Gastrointestinal disorders Diarrhoea	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Gastrointestinal disorders Dysphagia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Gastrointestinal disorders Pancreatitis	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Gastrointestinal disorders Peritonitis bacterial	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	2.8% 3/108 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Alcohol withdrawal syndrome	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Fatigue	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Hypothermia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Multi-organ failure	7.4% 7/95 • Number of events 7 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	9.3% 10/108 • Number of events 10 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Pyrexia	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Ascites	6.3% 6/95 • Number of events 6 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	12.0% 13/108 • Number of events 16 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Cholecystitis	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Cholestasis	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Nervous system disorders Hepatic encephalopathy	8.4% 8/95 • Number of events 11 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	5.6% 6/108 • Number of events 7 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Hepatic failure	13.7% 13/95 • Number of events 14 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	9.3% 10/108 • Number of events 10 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Hepatitis alcoholic	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	3.7% 4/108 • Number of events 4 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Hepatorenal syndrome	3.2% 3/95 • Number of events 4 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	8.3% 9/108 • Number of events 9 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Hepatobiliary disorders Hyperammonaemia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Gastrointestinal disorders Oesophageal varices haemorrhage	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	2.8% 3/108 • Number of events 4 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Bacteraemia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Clostridial infection	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Device related infection	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Device related sepsis	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Fungaemia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Gastroenteritis	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Mycobacterial infection	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Pneumonia	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	5.6% 6/108 • Number of events 6 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Rectal abscess	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Sepsis	4.2% 4/95 • Number of events 4 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Infections and infestations Urinary tract infection	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.

Other adverse events
Measure	ELAD Treatment n=95 participants at risk Participants randomized to the ELAD group received ELAD treatment plus protocol-directed Standard of Care treatment for a period of up to 5 days followed by Standard of Care treatment through Study Day 91.	Standard of Care (Control) n=108 participants at risk Participants randomized to the Control group received protocol-directed Standard of Care treatment in accord with AASLD and EASL guidelines for up to 91 days.
Blood and lymphatic system disorders Anaemia	44.2% 42/95 • Number of events 47 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	15.7% 17/108 • Number of events 19 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Anaemia macrocytic	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Anisocytosis	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Coagulopathy	30.5% 29/95 • Number of events 34 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	12.0% 13/108 • Number of events 15 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Disseminated intravascular coagulation	7.4% 7/95 • Number of events 7 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Haemolysis	3.2% 3/95 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Haemolytic anaemia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Hypochromasia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Hypofibrinogenaemia	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Hypoprothrombinaemia	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Leukaemoid reaction	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Leukocytosis	13.7% 13/95 • Number of events 16 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	12.0% 13/108 • Number of events 13 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Lymphadenopathy	3.2% 3/95 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Pancytopenia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Splenomegaly	3.2% 3/95 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders Thrombocytopenia	34.7% 33/95 • Number of events 36 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	11.1% 12/108 • Number of events 12 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Arrhythmia	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Atrial fibrillation	5.3% 5/95 • Number of events 6 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	1.9% 2/108 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Atrial flutter	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Bradycardia	4.2% 4/95 • Number of events 4 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	3.7% 4/108 • Number of events 7 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Cardiac arrest	1.1% 1/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Cardiac failure	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	2.8% 3/108 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Cardiac failure congestive	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Cardiomegaly	2.1% 2/95 • Number of events 2 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Chest discomfort	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
General disorders Chest pain	7.4% 7/95 • Number of events 8 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	3.7% 4/108 • Number of events 4 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Vascular disorders Dizziness	2.1% 2/95 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	11.1% 12/108 • Number of events 15 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Hyperdynamic left ventricle	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Left ventricular dysfunction	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Left ventricular hypertrophy	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Mitral valve incompetence	3.2% 3/95 • Number of events 3 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Metabolism and nutrition disorders Oedema peripheral	33.7% 32/95 • Number of events 38 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	30.6% 33/108 • Number of events 41 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Palpitations	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Pulmonary valve incompetence	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Right atrial dilatation	1.1% 1/95 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.00% 0/108 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Sinus tachycardia	7.4% 7/95 • Number of events 7 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Supraventricular tachycardia	0.00% 0/95 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	0.93% 1/108 • Number of events 1 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.
Cardiac disorders Tachycardia	17.9% 17/95 • Number of events 19 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.	9.3% 10/108 • Number of events 10 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria and were included in the Control group. One subject who randomized to Control but received ELAD treatment and this subject was included in the ELAD group. Therefore, 95 subjects were exposed to ELAD treatment and 108 subjects were exposed to Control.