Trial Outcomes & Findings for Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD (NCT NCT02612428)

Last Updated: 2019-01-25

Results Overview

The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTL-308E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (28 Aug 2018).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

151 participants

Primary outcome timeframe

Up to at least Study Day 91, with protocol VTL-308E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (28 August 2018).

Results posted on

2019-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	ELAD System This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
VTL-308 STARTED	78	73
VTL-308 COMPLETED	64	56
VTL-308 NOT COMPLETED	14	17
VTL-308E STARTED	64	56
VTL-308E COMPLETED	53	49
VTL-308E NOT COMPLETED	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	ELAD System This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
VTL-308 Death	14	16
VTL-308 Withdrawal by Subject	0	1
VTL-308E Death	9	7
VTL-308E Lost to Follow-up	2	0

Baseline Characteristics

Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELAD System n=78 Participants This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) n=73 Participants This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol	Total n=151 Participants Total of all reporting groups
Age, Customized Age · Between 18 and 35 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Customized Age · Between 36 and 50 years	55 Participants n=5 Participants	51 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	44 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	67 Participants n=7 Participants	137 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Austria	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	52 participants n=7 Participants	109 participants n=5 Participants
Region of Enrollment Ireland	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Germany	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Spain	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Baseline MELD Score	24.8 MELD Score STANDARD_DEVIATION 2.37 • n=5 Participants	25.6 MELD Score STANDARD_DEVIATION 2.35 • n=7 Participants	25.2 MELD Score STANDARD_DEVIATION 2.38 • n=5 Participants

PRIMARY outcome

Timeframe: Up to at least Study Day 91, with protocol VTL-308E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (28 August 2018).

Outcome measures

Outcome measures
Measure	ELAD System n=78 Participants This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) n=73 Participants This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
Overall Survival	55 Participants	51 Participants

SECONDARY outcome

Timeframe: Up to Study Day 91

Assess the proportion of survivors at Study Day 91

Outcome measures

Outcome measures
Measure	ELAD System n=78 Participants This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) n=73 Participants This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
Number of Survivors at Study Day 91	63 Participants	57 Participants

SECONDARY outcome

Timeframe: Up to Study Day 7

To estimate the effect of ELAD on the number of subjects achieving a 20% reduction in total bilirubin by Day 7 (ECBL20 Yes)

Outcome measures

Outcome measures
Measure	ELAD System n=78 Participants This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) n=73 Participants This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
Number of Subjects With Early Change in Bilirubin Levels at Study Day 7	38 Participants	24 Participants

Adverse Events

ELAD System

Serious events: 47 serious events

Other events: 76 other events

Deaths: 14 deaths

Standard of Care (Control)

Serious events: 42 serious events

Other events: 74 other events

Deaths: 17 deaths

Serious adverse events

Other adverse events

Additional Information

Robert Ashley, Chief Technical Officer

Vital Therapies, Inc.

Phone: 001 858-673-6840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	ELAD System n=76 participants at risk This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) n=75 participants at risk This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
Blood and lymphatic system disorders Anaemia	5.3% 4/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	4.0% 3/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Febrile Neutropenia	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Pulseless Electrical Activity	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Tachycardia	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Abdominal Pain	3.9% 3/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Alcoholic Pancreatitis	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Ascites	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	5.3% 4/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Gastritis	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Gastrointestinal Haemorrhage	7.9% 6/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	9.3% 7/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Haematemesis	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Pancreatitis	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Peritoneocutaneous Fistule	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Vomiting	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Generalised Oedema	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Medical Device Site Haematoma	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Medical Device Haemorrhage	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Multi-Organ Failure	9.2% 7/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	17.3% 13/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Oedema Peripheral	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Pyrexia	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
General disorders Systemic Inflammatory Response Syndrome	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Alcoholic Liver Disease	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Bioduct Stone	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Hepatic Cirrhosis	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Hepatic Failure	7.9% 6/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	6.7% 5/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Hepatic Function Abnormal	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Hepatitis Alcoholic	3.9% 3/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	5.3% 4/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Hepatorenal Failure	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Hepatobiliary disorders Hepatorenal Syndrome	9.2% 7/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	6.7% 5/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Immune system disorders Anaphylactoid Reaction	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Immune system disorders Drug Hypersensitivity	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Bacteraemia	3.9% 3/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	4.0% 3/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Cellulitis	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Erysipelas	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Peritonitis Bacterial	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	2.7% 2/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Pneumonia	5.3% 4/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	6.7% 5/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Sepsis	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Sepsis Syndrome	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Septic Shock	5.3% 4/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	5.3% 4/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Infections and infestations Urinary Tract Infection	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Injury, poisoning and procedural complications Head Injury	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.

Other adverse events
Measure	ELAD System n=76 participants at risk This group will receive treatment with ELAD plus standard of care therapy. ELAD System: An extracorporeal human hepatic cell-based liver treatment	Standard of Care (Control) n=75 participants at risk This group will receive standard of care therapy as defined in the protocol. Standard of Care (Control): Standard medical treatment as defined by the protocol
Blood and lymphatic system disorders Abdominal Lymphadenopathy	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Acquired Disfibrinogenaemia	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Anaemia	48.7% 37/76 • Number of events 42 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	24.0% 18/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Coagulopathy	18.4% 14/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	13.3% 10/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Hypofibrinogenaemia	6.6% 5/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Leukocytosis	17.1% 13/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	20.0% 15/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Lymphademopathy	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Neutropenia	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Neutrophelia	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Blood and lymphatic system disorders Thrombocytopenia	22.4% 17/76 • Number of events 18 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	10.7% 8/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Aortic Valve Incompetence	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Atrial Fibrilation	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Atrial Tachycardia	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Bradycardia	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	2.7% 2/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Cardiac Failure Congestive	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Cardiomegaly	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Cardiovascular Disorder	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Defect Conduction Intraventricular	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Dilatation Ventricular	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Heart Valve Incompetence	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Left Atrial Dilatation	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Left Ventricular Dysfunction	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Myocardial Infarction	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Palpitations	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Right Atrial Dilatation	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Tachycardia	11.8% 9/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	10.7% 8/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Tricuspid Valve Incompetence	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	2.7% 2/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Ear and labyrinth disorders Middle Ear Effusion	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Ear and labyrinth disorders Vertigo	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Endocrine disorders Adrenal Insufficiency	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	2.7% 2/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Endocrine disorders Hypothyroidism	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Endocrine disorders Secondary Adrenocortical Insufficiency	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Eye disorders Dry Eye	3.9% 3/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Eye disorders Vision Blurred	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Eye disorders Vitreous Floaters	0.00% 0/76 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	1.3% 1/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Abdominal Distension	2.6% 2/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	4.0% 3/75 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Abdominal Pain	21.1% 16/76 • Number of events 21 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	20.0% 15/75 • Number of events 18 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.
Gastrointestinal disorders Anal Fissure	1.3% 1/76 • 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 the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.	0.00% 0/75 • Randomization through Study Day 91. According to the SAP, Safety Population was used for the analysis of all adverse events and the Safety Population was defined according to the actual treatment received. Two subjects were not treated with ELAD because they did not meet the safety eligibility criteria before the start of ELAD treatment and they were included in the Control group in the Safety Population. Therefore, only 76 subjects were exposed to ELAD treatment and 75 subjects were exposed to Control.